clayton hotel burlington road, dublin eu mdr & …...amanda maxwell, medtech regulatory affairs...

12-16 OCTOBER 2020VIRTUAL EVENTDelivered in Central European Summit Time (CEST) Time Zone

EU MDR, IVDR AND GLOBAL MARKET REGULATIONS: BRINGING THE LATEST GUIDANCE TO YOU

informaconnect.com/medtech-summit#MEDTECH | @MedTechIC

Join the European Commission, Competent Authorities, Notified Bodies and industry online for the answers you need to accelerate your path to complianceGet the same dedicated coverage of PMS & Vigilance, Clinical Strategies, Combination Products, Software, Law, Biocompatibility and Medical Device Regulatory Project Management, from the comfort of your own seat

Event Partner

MEDTECH SUMMIT AT A GLANCE

DAY 1Monday 12th October

DAY 2Tuesday 13th October

DAY 3Wednesday 14th October

DAY 4Thursday 15th October

DAY 5Friday 16th October

TRAINING COURSETuesday 27th October - Friday 30th October

EU Medical Device Regulation

EU Medical Device Regulation

Medical Device Regulatory Affairs in

Global Markets

Medical Device Regulatory Affairs in

Global Markets

Medical Device Regulatory Project

Management14:00 - 17:00

4 Day Training Course 3 Hours Per Day

EU Medical Device Law

Clinical Evaluations & Investigations

Clinical Evaluations & Investigations Software & AI Drug Device

Combination Products

Post Market Surveillance & Vigilance

Post Market Surveillance & Vigilance

EU IVD Regulation & Strategy

EU IVD Regulation & Strategy

Biocompatibility for Medical Devices

Biocompatibility for Medical Devices

2 • informaconnect.com/medtech-summit • #MedTech | @MedTechIC

THE VIRTUAL MEDTECH EXPERIENCE: WHAT TO EXPECT...


The virtual conference has been tailored towards you and your ease. While many are unable to travel and social distancing measures remain an integral part of the global climate, the EU MDR, IVDR and global market regulatory deadlines still remain. And we’re here to help!

Time-critical Insights Without The Need To TravelGet direct access to the information and people you need to get your questions answered. Enjoy the same regulatory guidance and practical examples that the event is renowned for with access to some of the industry’s biggest names, and benefit from interactive networking opportunities - all at the touch of a button.

Access Regulatory Know-How At A Time That Suits YouAccess the extensively researched 9-track agenda and view it at your own pace. Tune-in for direct regulation and strategy advice and get the answers you need to overcome your compliance hurdles. And, with all presentations made available both live and on-demand for after 30 days, you will be able to attend more presentations than ever before!*Excluding sessions limited to live viewings only. Subject to speaker permissions.

Reshaping Your Networking ExperienceOur digital event platform offers a sophisticated and fully interactive conference experience. Tune-in live to put your questions forward during speaker Q&As and panel discussions, arrange one-to-one and group video meetings with speakers, sponsors and other delegates from around the globe, and form connections with leading experts through interactive networking sessions and round table discussions.

The MedTech Summit Virtual conference will be delivered live

in Central European Summer Time (CEST) Time Zone.

AGENDA: DAY 1: MONDAY 12TH OCTOBER 2020

10.00 Platform Tutorial

EU Medical Device Regulation EU Medical Device Law10.30 Session Moderated by

Amanda Maxwell, Managing Editor, Informa, UK Session Moderated byJosefine Sommer, Senior Associate, Sidley Austin LLP, Brussels

10.40 Path to Compliance: Industry EU MDRTips and tricks for streamlining the EU MDR certification processBiggest hurdles faced with the EU MDRKey strategies that help achieve EU MDR statusDifferences between class 1 and class 3 compliance paths

Shokoufeh Khodabandeh, MDR Implementation Lead, Institut Straumann AG

Implementation of the Person Responsible for Regulatory Compliance (PRRC) in your Organisation• Roles, responsibility and liability for the named individual responsible for EU MDR• Understand thea lines between personal and organisation liability and risk• Examining European national legislation and the impact on the accountability for PRRC• How is PRRC being used as an extra means to increase the level of compliance of

manufacturers?James Whitehead, Patient Safety Medical Device Lead, AstraZeneca, UKAlex Denoon, Partner, Bristows LLP, UK

11:10 Impact of COVID19 on the EU MDRErik Vollebregt, Partner, Axon Lawyers, The Netherlands

Legal Advice on the Economic Operators Regime: Have You Gone Far Enough?• Definitions of manufacturer, importer and distributor (MAID) and the impact of tax

structures• What should be in your commercial contracts and quality agreements through the supply

chain?• How to leverage your supply chain in light of Post Market Surveillance requirements under

the EU MDR• Working with your Notified Body on the economic operator’s regime• Preparation for audit: Legal tools to manage and demonstrate compliance• Distributor perspective on the new economic operators’ regimePeter Bogaert, Partner, Covington & Burling LLP, Belgium

AGENDA: DAY 1: MONDAY 12TH OCTOBER 20204 • informaconnect.com/medtech-summit • #MedTech | @MedTechIC

All live presentation times listed are in Central European Summer Time (CEST) Time Zone.

11.40 PANEL DISCUSSION: Industry Feedback on the Implementation of the EU MDR• Reviewing the process of becoming EU MDR compliant• Which processes worked as planned and which didn’t?• Understanding where the bottlenecks were? Are?• Were the resources as expected in regard to time, money and staff?• Addressing the extent of reliance on transitional provisions• Which aspects took longer than planned?• The stumbling blocks throughout the processJuliette Cook, Regional Regulatory Director EMEA, Cochlear, SwitzerlandInge Vandenbussche, Director Regulatory Affairs EMEA, Medtronic, United StatesShokoufeh Khodabandeh, EU MDR Implementation Lead, Straumann, SwitzerlandDaniela Leal, Regulatory Affairs Team Leader, Zimmer BiometAlexander Natz, Director General, EUCOPE, Belgium

Transitional Provisions under the EU MDR and IVDR• Key transitional provisions and understanding the legal meaning for the provisions• Understanding what constitutes a significant change in design or intended purpose• What will the transitional period look like for companies?• Competitive monitoringDavid Van Passel, Legal Director – Regulatory Law EMEA & APAC, Johnson & Johnson, Belgium

12.25 - Networking Break – A chance to connect with stakeholders, sponsors and fellow attendees MedTech Law Roundtable moderated by Mason, Hayes & Curran

Session Moderated by Amélie Chollet, Legal Regulatory Counsel, Abbott Laboratories, UK

13.35 National RequirementsGavia Taan, Unit Manager – Devices Regulatory Policy Devices Division, MHRA, UK

14.10 EU Medical Device Regulations, Notified Body Overview and Update from BSIMaddalena Pinsi, Regulatory Manager, Regulatory, Services, Notified Body, BSI

Suzanne Halliday, Regulatory Director & Head, Notified Body, BSI

14.45 - Networking Break – A chance to connect with stakeholders, sponsors and fellow attendees

14:45 Tech Tour: Mason Hayes and Curran

15:00 Tech Tour: BSI

Session Moderated byDaniela Leal, Regulatory Affairs Team Leader, Zimmer Biomet

Session Moderated byAnnabelle Bruyndonckx, Of Counsel, Simmons and Simmons, Brussels

5 • informaconnect.com/medtech-summit • #MedTech | @MedTechIC AGENDA: DAY 1: MONDAY 12TH OCTOBER 2020


66 • informaconnect.com/medtech-summit • #MedTech | @MedTechIC AGENDA: DAY 1: MONDAY 12TH OCTOBER 2020


15.45 How Technology Can Simplify Compliance in the World of Global Regulatory ChangesSession Moderated by: Daniela Leal, Regulatory Affairs Team Leader, Zimmer Biomet• The ‘new normal’ for regulatory professionals: Managing regulatory information in a

dynamic global environment• Keeping up with the pace of international regulatory change: Improving efficiency through a

global platform approach• Prioritizing needs: Driving process consistency, addressing regulatory complexity and

speeding time to marketAnnemien Pullen, Director Strategy, Vault Medical Devices & Diagnostics, Veeva Systems, The Netherlands

Your Legal Relationship with your Notified BodySession Moderated by:• The ability to challenge: Can you challenge the legal decisions of your Notified Body?• Susceptibility to freedom of Information applications• When is changing a Notified Body allowed?• Legal advice on involuntary change of your Notified BodyErik Vollebregt, Partner, Axon Lawyers LLP, The Netherlands

16.15 How to Achieve the CE Mark for Medical Devices• Assessing the biggest hurdles to conformity assessment and how these were handled• What I would do differently?• Advice to reach EU MDR complianceJeffrey Cyr, Senior Manager, Regulatory Affairs, Sirtex Medical Inc., United States

Article 7: Putting Claims Requirements into Practice - Labelling, Advertising & Instruction• Specific rules on liability claims in the EU MDR: Ensuring you meet Article 7 conditions for

standards on failing to inform • Provision of public information: Guidance on listing adverse events, side effects and risk• Practical guidance on next steps for manufacturers: Careful vetting of supporting evidence

and safeguarding for competitor challenges to claims• Update on regulations, promotion and advertising for medical devices across Europe• Understanding liability when lines are crossed on digital platforms and social media• Promotional issues for combination pharmaceuticals with devices Laure Le Calvé, Managing Partner, LCH, France

16.45 EU MDR: End of transition period – What happens to the EU Medical Device Market next?• Global Impacts: Coronavirus & Economic downturn• Local impacts: Brexit & Lack of Notified Body capacities• Most relevant Regulatory topics under MDR• Transformation for future success to benefit from MDROliver Christ, Heath Sciences Managing Director EMEA, NSF, Germany

Product Liability, Sufficient Financial Coverage and EU MDR: Where are we?• Specific rules on liability claims under the EU MDR • Concept of sufficient financial coverage as a quality management requirement: What does

this mean in practice?• Update on the European product liability regime • Latest developments for the collective redress directive and legal considerations• Guidance on identifying your potential liability and mitigating risksMichaela Herron, Partner, Mason, Hayes & Curran, Ireland

17.15 - Taste of Dublin 17:25 Speed Networking

AGENDA: DAY 2: TUESDAY 13TH OCTOBER 2020

EU Medical Device Regulation Clinical Evaluations & Investigations Post Market Surveillance & Vigilance

09:00 - Let’s get Moving - PT Session

10:00 - Platform Tutorial

10:20 - Opening Remarks from Event Producers

Session Moderated by Richard Houlihan, CEO, EudaMed.eu, Belgium

Session Moderated by Gert Bos, PhD, Executive Director & Partner, Qserve Group B.V, The Netherlands

Session Moderated by Fayez Abou Hamad, MD, Vigilance Expert Consultant – Pharmacist, TERUMO EUROPE

10.35 Smooth Operator: Implementing EO Requirements from the EU MDR• What Is an Economic Operator?• How do you keep your EO Chain under control and

compliant according the EU MDR?• What are (some) EO activities/obligations?• Steps to implementation• Current state• ChallengesClaire van den Nieuwenhof, EMEA Regulatory Affairs, Medical

DEEP DIVE CASE STUDY: Industry Feedback on the Clinical Module• Hands on experience on preparing the clinical module for

the EU MDR• Understanding the pitfalls during the process• What was the expected time and effort into the CER?Shelley Jambresic, Clinical Research Manager & Science Writer, Geistlich Pharma AG, Switzerland

NOTIFIED BODY FEEDBACK: Post Market Surveillance - How to Succeed in the First Year Under EU MDR• Advice on building a robust Post Market Surveillance

system • Tips and advice to prepare the PMS plan and PMCF plan• How to take advantage of the one-year postponement of

MDR for collecting useful dataDaniele Bollati, Product Conformity Assessment, IMQ, Italy

11.05 Creating a Robust QMS System that can Successfully Process the EU MDR• Feedback from industry on updating QMS systems from the

EU MDD to the EU MDR and having parallel QMS systems between May 2020 to May 2024

• Tips to ensure an easy to navigate QMSDaniele Bollati, Product Conformity Assessment, IMQ, Italy

Sufficient Clinical Evidence for legacy devices under MDRThis is a discussion on “sufficient clinical evidence”, including MDCG 2020-6 guidance, from one of the authors of that guidance document. This session will also include an overview of the following:The link between intended purpose, clinical benefit, and “specific and measurable endpoints”What is meant by “WET”? Tips for tackling “high risk” WET that have little or no clinical evidence.When can you use Article 61(10)?Amie Smirthwaite, Senior Director - Global Clinical Practice, Maetrics

MANUFACTURER PERSPECTIVE: Interpreting the Requirements for Post Market Surveillance Under the EU MDR• Industry interpretation of the Post Market Surveillance

requirements• How data systems need to be updated and with what

information• Example of full Post Market Surveillance plansYaman Tunaboylu, Post Market Surveillance Manager, BioTronik AG, Switzerland

12.05 - Networking Break – A chance to connect with stakeholders, sponsors and fellow attendees Including Roundtable from BSI

13:20 - Feedback from European Commission: Notified Bodies Designation Session Moderator by Bassil Akra, CEO, QUNIQUE GmbH, Germany

Máiréad Finucane, Project Lead & Inspector for Joint Assessments of Notified Bodies (Medical Devices), DG Sante, European Commission, Ireland

AGENDA: DAY 2: TUESDAY 13TH OCTOBER 20207 • informaconnect.com/medtech-summit • #MedTech | @MedTechIC


13:55 - NOTIFIED BODY PANEL DISCUSSION: EU MDR Pain Points • Update on who has received Notified Body designation

• How many Notified Bodies are in the pipeline and what are the timelines for designation?• Q&A with Notified Bodies

Dr Elaine Darcy, European Medical Device Operations Manager, NSAI, IrelandMartin Witte, Global Director, Active Implantable and Cardiovascular Devices, TÜV SÜD, The Netherlands

Yvonne Ndefo, Chief Clinical Evaluator, NSAI, IrelandDaniele Bollati, Product Conformity Assessment / Medical Devices Expert, IMQ

Bart Mersseman, Certification and Business Enhancement, Global Medical Devices Certification Manager, SGS, Belgium

14:50 - Tech Tour: Cactus

15:05 - Tech Tour: Maetrics

15:20 - Tech Tour: Thera-Business

15:30 - Networking Break – A chance to connect with stakeholders, sponsors and fellow attendees

Session Moderated by Jeffrey Cyr, Senior Manager, Regulatory Affairs, Sirtex Medical Inc., United States

Session Moderated by Melanie Crystal

Session Moderated by Fayez Abou Hamad, MD Vigilance Expert Consultant – Pharmacist, TERUMO EUROPE

15:45 EUDAMED UPDATE: Status and Future Timelines of Implementation of the EUDAMED Database• Addressing the causes of delays to EUDAMED modules (EC

& Industry responsibilities) – actions (if any)• Proposed IT support for Economic Operators• Stages of registering people to the database: How is this

done in practice? – Registrations, Validations and SRN issuing

• Outlining the complexity and sheer size of the EU MDR EUDAMED

• Reassurance that the database can function with a large workflow of data

• Data input options overview – in-house and 3rd party options

— Warning about public availability of the data• Changes and IT project – long term maintenance and

implications— Required IT skills gap analysis• What can companies do now to be prepared?Richard Houlihan, CEO, EudaMed.eu, Belgium

Optimal Use of Scientific Literature to Ease Your Path to EU MDR Compliance• Importance of scientific literature in the EU MDR• Embedding scientific literature into your plans• Key methodological approaches for obtaining your

scientific literature • Ensuring a continuous life cycle of scientific literatureDr. Isabella Steffensen, President, Thera-Business

Streamlining the Post-Market Surveillance Planning for Biomedical Literature• Applications of peer-reviewed literature for the MDR• Identifying medical device information from biomedical

literature• Identifying directly linked adverse device effects for a

specific medical device and patient group from clinical studies

• Automating the post-market surveillance plan with regular updates on relevant medical device safety signals

Iveta Petrova PHD, Lead Product Manager Embase, Elsevier

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16.15 Implementing a UDI System to Meet EU MDR and Global Requirements• Why UDI? Business strategies, uses and requirements• Developing, implementing and maintaining a UDI program — Differences between Basic UDI-DI (BUDI), UDI-DI and UDI-PI— EUDAMED UDI Requirements— Process of procuring UDI numbers• Communicating UDI to Customers and End Users -

Labelling and other requirements• Developing a Global UDI strategy - harmonizing US FDA UDI,

EU MDR UDI and the rest of the world requirementsKristopher Williams, Associate Director, Engineering Services EU MDR Core Team, Zimmer Biomet, United States

Developing a Strategic Outlook on Clinical Evaluation Plans• Creating a plan that works towards explaining claims rather

than regulatory compliance• Defining product claims to ensure it doesn’t hinder data

requirements• Examples of how phrasing will change outcomes of

expectations of trial• Building a robust evidence plan to meet CER requirements • Future proofing your CER by using stakeholders to develop

long term strategyDr Juliana Witte, Clinical Evaluation Manager, Straumann, Switzerland

Creating a Robust Post Market Surveillance Plan Under the EU MDR• Streamlining timelines for Post Market Surveillance plans• Strategies for implementation of Post Market Surveillance

under the EU MDR• Avoiding common pitfallsPhilippe Auclair, Senior Director, Regulatory Strategy & Advocacy, Abbott Quality & Regulatory Belgium

16.45 Update on ISO/TR 24971 Guidance Document • Clinical risk requirements that need to be met under new

guidance • Understanding how this fit into the EU MDR• Guidance for compliance with the both ISO and EU MDR Jahan Azizi, Special Projects Manager, Healthmark Industries, United States

Using Real World Evidence for Medical Device Post Market SurveillanceAlexandros Charitou, Director, Life Sciences, Guidehouse (formerly Navigant), UK

17.10 - Speed Networking

9 • informaconnect.com/medtech-summit • #MedTech | @MedTechIC AGENDA: DAY 2: TUESDAY 13TH OCTOBER 2020


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AGENDA: DAY 3: WEDNESDAY 14TH OCTOBER 2020

Medical Device Regulations in Global Markets Clinical Evaluations and Investigations Post Market Surveillance & Vigilance Session Moderated by Hyun-Woo Cho, Manager Regulatory Affairs, Asahi Intecc Co., Ltd, The Netherlands

Session moderated by Bassil Akra, CEO, QUNIQUE GmbH, Germany

Session Moderated by Gert Bos, PhD, Executive Director & Partner, Qserve Group B.V, The Netherlands

10.35 CHINA COMPETENT AUTHORITY PERSPECTIVE: Keeping Pace with Chinese Regulations - Practical Advice for MedTech Manufacturers Moderators:• NMPA priorities and focuses: Sharing regulatory insight and

timeframes• Examining differences and divergence to international

regulations: Avoiding common trip points for international firms

• Unique Device Identification (UDI) implementation timeframes: Next steps towards enforcing UDI requirements

Ren Dazhi, ARQon China, and former Device Classification and Standards Executive Committee Member, National Medical Products Administration (NMPA), China

NOTIFIED BODY FEEDBACK: Summary of Safety of Application Performance Requirements• Expectations on industry from Notified Bodies for SSCPs• Guidance for SSCP explained• Explaining how many versions are required – one for expert

and layperson?• How to populate the document?Melania Battistella, Global Manager of Aesthetic Products, Clinical Reviewer and Clincial Team Lead, TÜV SÜD, Italy

NOTIFIED BODY FEEDBACK: PSUR Forms• Explaining the PSUR Guidance document• Tips and tricks for successful PSUR forms• How the data from these forms is used by Competent

AuthoritiesMax Singh, Global Director, TÜV SÜD, The Netherlands

11.05 CHINA Get Ready: Be Prepared for NMPA Focus on Post Market Surveillance• Keeping your hard-won registrations under increased focus

on post market surveillance • Post market documentation requirements for product

renewals• Practical insight into the management and data reporting

for post market compliance• How to incorporate NMPA GMP requirements into your

QMS/GMP systemChao Xu, Co-Founder &VP International Business, JMEDTEC, China

First Experiences of Creating a Summary of Safety Application Performance Review• Hands on experience from first SSCP forms• Pitfalls: easier or harder than expected• Time dedicated to this• Manpower dedicated to this• Examples of documents that have been accepted• Showcasing successful examples• Avoiding mistakes made with populating the form• The importance of languageHuajie Bu, Clinical Evaluations Manager, Medel, Austria

First Experiences with Manufacturer’s Incident Report New Guidelines• First experiences from MIRs• How is this working in practice?• Best practices to simplify the process• Streamlining the MIR processLaure-Anne Thieren, Manager Business Process, Quality & Compliance, Johnson & Johnson, Belgium

10 • informaconnect.com/medtech-summit • #MedTech | @MedTechIC AGENDA: DAY 3: WEDNESDAY 14TH OCTOBER 2020


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11.35 ASEAN COMPETENT AUTHORITY PERSPECTIVE: Leveraging ASEAN Regulatory Harmonisation to Streamline Registration in South East Asia• 2020 deadline is here! Evaluating next steps, successes and

challenges• Updates on the adoption, challenges and implementation

progress of ASEAN MDD • Update on Thailand regulatory redesign and reclassification

programme• Manufacturer’s shortcuts to regulatory access and

registration Sasikala Devi, Director, Policy, Code & Standard Division, Medical Device Authority, Ministry of Health, Malaysia

Common Pitfalls in Medical Device Studies - How to Mitigate and Prevent ThemWhile the EU MDR is placing more pressure on clinical teams to deliver quality evidence, company management strives to keep expenses down. To maximise resources and overcome new challenges brought on by new regulatory requirements, clinical teams need to eliminate typical issues that can hinder a successful transition towards compliance.As a service provider for MedTech clinical teams, there are several pitfalls we’ve observed repeatedly in various kinds of clinical studies. In this session, I will share our insights and experience on these common pitfalls and provide advice on how to mitigate and prevent them.• Why is it important to get the sample size right, and how do

you do it?• Ensuring data quality. What is considered satisfactory?• Lack of data and motivation. How to get clinical

collaborators onboard with your study.• Myths about GDPR. Are you missing out on vital data?Jón I. Bergsteinsson, VP of Global Business Development, SMART-TRIAL

Ensuring You Have a Robust Complaint Handling Programme in Place• Examples of compliant systems in place• Showcasing how this data is collected and stored• Best practices for processing complaints• Incident reporting under EU MDR while EUDAMED is not yet

in place• Post Market Surveillance and VigilanceJaklin Aziz, Quality Manager – Post Market Surveillance Product Quality, Resmed

12:05: Taste of Dublin

12:15 Networking Break - Break – A chance to connect with stakeholders, sponsors and fellow attendees Chinese Registration Roundtable

moderated by Aqron

Session Moderated by Bhaveeka Dattani, Senior Manager, Medical Devices and Combination Products, Regulatory Affairs - Strategy, Allergan Aesthetics, UK

Session Moderated by Sabina Hoekstra-van den Bosch, TÜV SÜD

Session Moderated by

13.20 SOUTH KOREA Identifying Easy Win’s to Registration for South Korea• An overview of the South Korean regulatory framework and

requirements for product registration• Practical considerations and easy wins when preparing

Korean MFDS medical device registration documents• Focusing in on the similarities and differences between US

and EU requirements • Best practice for working with Korea License Holders• Requirements and implementation for a Korean Unique

Device Identification (UDI) system Hyun-Woo Cho, Manager Regulatory Affairs, Asahi Intecc Co., Ltd, The Netherlands

Streamlining the Processes Between Clinical Evaluation and Post Market Surveillance to Better Leverage Data• Examining the crossover points between the deliverables needed to achieve EU MDR compliance

• The interface between different sub systems and strategies to improve their communication• Best practices to schedule deliverables

• Building communication between Post Market and Clinical DepartmentsGert Bos, PhD, Executive Director & Partner, Qserve Group B.V, The Netherlands



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13:50 Asia Regulatory strategy and tipsJack Wong, Founder of ARPA (Asia Regulatory Professional Association) and Associate Vice President Regulatory Affairs, Asia Pacific, Middle East & Africa Allergan, Singapore

Large and SME Manufactures: How to Handle Post Market Clinical Follow Up (PMCFs)?• Examples of PMCFs• The standards used to produce PMCFs• The balance between pre and post market data for PMCFAlexandra Rieben, Global Lead Clinical Research & University Account Management, Nobel Biocare Services AG, Switzerland

14.25 Strategies to Manage your Distributor Regulatory Risk• How to find a good partner: due diligence and best practice

when engaging a third party• Managing distributors and agents: practical checks and

balances when implementing and monitoring new regional regulations and codes

• Medical Device Regulatory Affairs in Global MarketsMaham Ansari, Director of Regulatory Affairs, Synaptive Medical, Canada

Less than a year to go: Is “Sufficient” evidence any clearer?• What is “sufficient” evidence?• Experiences and feedback of explaining your definition • Understanding the data expectations for clinical evidence

in both the US and EU• How to support products already on the market? Bassil Akra, CEO, QUNIQUE GmbH, Germany

MANUFACTURER’S PERSPECTIVE: PSUR process• How these have been implemented by manufactures• Examples of successful forms• Understanding where the data is coming from• Best practice for compliant PSURsEliza Raymundo, Associate Director Clinical Risk Management Global Regulatory Operations, Abbott, United States


15:10 Tech Tour Covance

15:25 Tech Tour Medei/Smart-Trial

15:40 Tech Tour Instem

Session Moderated by Shelley Jambresic, Clinical Research Manager & Science, Writer, Geistlich Pharma AG, Switzerland

Session Moderated by Rossella Messina, Senior Manager Oncology- Safety Risk Lead, Pfizer




16.05 JAPAN Shortcuts to Swift and Cost-Effective Registration in JapanModerator:• An update on the status of Japan’s MDSAP program and

future outlook • Preparing PMDA’s Foreign Manufacturer Registration

(FMR) application• Costs, timelines, best practice and practical insight into

working with Marketing Authorization Holder (MAH) to achieve your FMR swiftly

• Review of PMDA requirements for device testing and clinical evaluation

Bill Kurani, Head and Director of Regulatory Affairs & Quality Assurance, Agilent, United States

The Anatomy of Clinical Judgment for the Process of Clinical Evaluation• The nature and process of clinical judgment• Exploring how data are used in clinical judgment-making • Optimizing uncertainties for clinical evaluators• Applications for regulatory problem solvingRobert Mikan, MD, MBA, Medical Director (Global), Cactus Life Sciences, United States

Meeting the New PMS Reporting Requirements of MDR & IVDR with Future-Proof SystemsMarc Miller, Transperfect

16.35 CANADA Registration in Canada: Navigating Mandatory MDSAP and Evolving Regulations• Canadian regulatory framework and requirements for

product registration• Practical guidance on registrations, common

nonconformities and trip points• Sharing experiences and advice for successful MDSAP

audits and the practical impact of requirements for• MDSAP certification to sell medical devices in the Canadian

marketBill Kurani, Head and Director of Regulatory Affairs & Quality Assurance, Agilent, United States

Understanding Key Reimbursement Concepts to Optimize Design DecisionsUntil recently, medical device companies were primarily focused on designing and earning regulatory clearance for their new technologies. While innovative design and FDA/EMA approval are important for market entry, reimbursement is now a top concern for medical device executives, their investors and other healthcare stakeholders. This presentation will describe the key elements for reimbursement success, including an overview of coverage, coding and payment; advice for developing an effective reimbursement strategy; and information about the importance of demonstrating clinical and economic value for new technology. Case studies will also be presented to illustrate reimbursement challenges and successes for new medical technology entering the U.S. market.

Thomas Hughes, JD, Senior Principal Advisor, Health Economics & Reimbursement Medical Device & Diagnostic Solutions, Covance

Risk Management and the New IMDRF Problem CodesKim Trautman, Executive Vice President, Medical Device International Services NSF, United States

17.05 Industry Feedback: Conducting virtual inspectionsSusana de Azevedo Wäsch, Head of Global Regulatory Affairs, Geistlich Pharma AG, Switzerland

Speed Networking


Medical Device Regulatory Affairs in Global Markets Software & AI EU IVD Regulation and Strategy Biocompatibility for

Medical Devices Session Moderated by Agustina Susott, Regulatory Affairs Consultant, Switzerland

Session Moderated by Koen Cobbert Session Moderated by Marta Carnielli, Senior Manager, Safety Risk Management & Surveillance, TÜV SÜD, Italy


10:00 - Platform Tutorial

10:10 - Taste of Dublin

10:20 - Opening Remarks

10.35 SPOTLIGHT ON THE UK Placing Medical Devices on the UK Market from 1 January 2023Moderators:• What is the future landscape for the

regulation of medical devices in the UK?• What the UKCA mark and the UK(NI) mark

mean for manufacturers• Northern Ireland: the frontier for CE marked

devices?• Medical Device Regulations in Global

MarketsAlison Dennis, Partner, Taylor Wessing, UK

Regulatory challenges for AI according to the EU MDRDr Matthias Neumann, Deputy Head, BMG, Germany

NOTIFIED BODY UPDATE: EU IVDR Implementation• Feedback on the timeline for Notified Body

designation and current designations received

• The impact on workload for the Notified Bodies with designations and how this will impact industry

• Defining the standards, clarifying the requirements and understanding what Notified Bodies are looking for from industry

• Advice for industry on how to best prepare for the IVD audit and what to expect

Dr Andreas Stange, Vice President MHS Global IVD, TÜV SÜD, Japan

Current and Upcoming Challenges in ISO 10993• Replacing tick boxes with a risk

assessment• Key developments in the last 18 months

(ISO 10993-1 and -18)• Matching test method specificity to the

role in the risk assessment• Developments in ISO 10993 Parts 12, 23,

10, 18 and 5• Availability of the necessary expertise • Implications of the risk management

process• Application of ISO 10993-1 Annex B and

the revision of ISO 10993-17• Application of ISO/TR 24971 E.3 c Jeremy Tinkler, Chairman of ISO/TC 194 (biological and clinical evaluation of medical devices), Director of Regulatory Consultancy and Quality Assurance, MedPass International, UK

11.05 Registration Systems in Russia: Similarities and Differences to EAEU Regulations• Sharing experiences and strategies for

bringing products to Russian market• Challenges, opportunities and best practice

during the registration process• Regulatory vs sales best practice• Similarities and differences to EAEU

regulationsRuslan Kalachev, Development Director, BeAWire LLC, Russia

Neural Networks and Continuous Machine Learning Software• The impact of black box design and model

diversification after deployment• Compliance implications with regards to

regulations and current state-of-the-art standards

• Traceability of continuously evolving software and its impact on market surveillance and vigilance

Pat Baird, Regulatory Head of Global Software Standards, Philips, United States

Guidance on the Classification Process for IVDs• An update on the guidance’s for

classification• Understanding the different classifications

for IVDs under the EU IVDR• Feedback on the guidance documents

available for classificationLakshman Prakash Balajepalli, Head of Regulation and Quality, RAS Lifesciences, India

AGENDA: DAY 4: THURSDAY 15TH OCTOBER 2020

AGENDA: DAY 4: THURSDAY 15TH OCTOBER 2020



11.35 BRAZIL COMPETENT AUTHORITY PERSPECTIVE: Tools and Tips for Navigating the Complexities of Brazil’s Regulatory Requirements• Discussing the current regulatory

requirements for medical device registration and ANVISA plans for the future

• Insight into recent changes: Software regulations, reusable medical devices and INMETRO Ordinance 54/2016 certification review

• Practical guidance on registrations, common nonconformities and answering your questions

Augusto Bencke Geyer, Advisor of the General Management of Technology for Health Products, ANVISA, Brazil

CASE STUDY: Machine Learning as a Medical Device• Regulatory requirements of machine

learning under the EU MDR and IVDR• The impact of black box design and model

diversification after deployment• Compliance implications with regards to

regulations and current state-of-the-art standards

• Traceability of continuously evolving software and its impact on market surveillance and vigilance

Johan Ordish, Senior Policy Advisor, PHG Foundation, Germany Alison Hall, Head of Humanities, PHG Foundation, Germany

Industry Preparations for the EU IVDR• Interpreting the guidance around common

specifications and product groups• Tips for successful implementation of the

EU IVDRAlexandra Stamati, Director, Quality Assurance-PRRC, Medicon Hellas SA, Greece

Spotlight Session from Nelson Laboratories

12.05 - Networking Break – A chance to connect with stakeholder, sponsors and fellow attendees including roundtable by Toxikon

Session Moderated by Koen Cobbert Session Moderated by Anja Wiersma, PhD; CEO, mi-CE consultancy, The Netherlands


15 • informaconnect.com/medtech-summit • #MedTech | @MedTechIC AGENDA: DAY 4: THURSDAY 15TH OCTOBER 2020


13.20 PANEL DISCUSSION Preparing your Organisation for MDSAP• Experience of acceptance of MDSAP

audit approval across the other member regulatory jurisdictions

• How are inspections run and how are local authorities interpreting audit findings in practice?

• Sharing experiences and advice for successful MDSAP audits

• Common challenges: Manufacturer buy-in, time, audit costs, and resource limitations

Hendrik Heinze, Director Quality and Regulatory Affairs, Berlin Heart, Germany Georg Bauer, Department Manager Foreign Affairs, TÜV SÜD, GermanyAugusto Bencke Geyer, Advisor of the General Management of Technology for Health Products, ANVISA, Brazil

Reimbursement of Digital Health Solutions• Insights into the digital health landscape • How does it work to get reimbursement?

Which parties are involved? What can be reimbursed, what cannot?

• Regulatory considerations in the product lifecycle

• Pricing – let’s talk about moneyLaurent Louette, Communications & Public Affairs Manager, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)

COMPETENT AUTHORITY PERSPECTIVE: Practical Considerations for Preparing for the EU IVDR• The 2-year countdown has started – where

are we?• Feedback on available guidance’s for the

EU IVDRStephen Lee, MHRA

Guidance on the new ISO 10993 – 18Highlighting the biggest differences between the old and new -18• Outline of the new content of – 18• AET• The solvents• Understanding the flow charts in -18• Conducting a GAP analysis to know which

tests to doTed Heise, Vice President Regulatory and Clinical Services, MED Institute, United States

13:55 DUAL DIALOGUE: A Digital Health Love Story - The Convergence of AI, Healthcare Data and Medical Devices• The growth and role of digital health in the

Medtech sector• Legal regulatory framework for medical

device digital health• Examining IP and data compliance

considerations for healthcare data and AI• Practical considerations and

future synergies for medical device manufacturers and digital health firms

Giorgio Rizzello, Legal Director EMEA, Johnson & Johnson, BelgiumCarmelo Fontana, Senior Regional Counsel, Google, Italy

Regulatory Update from BSIInitial experiences of applications under the IVDR – A Notified Bodies ViewEU IVD Regulation and Strategy

Erica Conway, Global Head – IVD, BSI

Regulator View: Assessment and review by “knowledgeable and experienced professionals” and Fast-track approval of medical devices• Assessment and review by “knowledgeable

and experienced professionals”• Lack of expertise of assessors and

reviewers• Defining requirements for expertise and

qualification• Fast-track approval of medical devices

during unprecedent medical need – perspective from the regulator

• The role of biocompatibility when getting devices onto the market during a pandemic

• Principles underpinning the selection of the minimally acceptable biological safety requirements for the air pathway of a ventilator during COVID-19

Michelle Kelly, Senior Medical Device Specialist, MHRA, UK

14:25 - Let’s Get Moving- PT Session

15:20 Tech Tour: IVDedology

Session Moderated by Koen Cobbert Session Moderated by Marta Carnielli, Senior Manager, Safety Risk Management & Surveillance, TÜV SÜD, Italy




15.30 MEXICO Efficient Submission Routes for Registration in MexicoModerators:• Registration requirements in Mexico:

Classification schemes and registration pathways

• Understanding the mindset and avoiding trip points: Practical advice for managing expectations and regulatory requirements during registration with COFEPRIS

• Quality management system and in-country representation requirements

Agustina Susott, Global Regulatory Affairs Consultant, Austria

Artificial Intelligence (AI): Practical Applications to Meet MDR & IVDR Labeling RequirementsNew applications for artificial intelligence (AI) are being developed across the medical device industry. However, with proper technology and approach, AI is already in use and delivering results for translated IFUs and other labeling content. Learn how you can use AI now to support your MDR or IVDR labeling requirements (including client case study).

Kai Simonsen, VP of Production and Quality Systems for TransPerfect Medical Device

Clinical Evidence & Performance Evaluation Studies for IVDsThis presentation will expand on practical advice on the three clinical evidence pillars:• Scientific validity reports & how to prepare

them• Practical approach to Analytical

Performance• Practical approach to ClinicalPerformanceMaurizio Suppo, Vice President Regulatory Affairs, QARAD, Italy

Industry Experience of Chemical Characterisation• Practical feedback on conducting chemical

characterisation for devices• Understanding when it is necessary to do

Chemical characterisation• Experiences with justifying the chemical

characterisation process• What questions were asked by Notified

Bodies on your choices?• How has feedback from your NB or FDA

changed your approach to Chemical Characterisation?

Charlotte Laupheimer, Preclinical Research Manager & Medical Writer, Geistlich Pharma AG, Switzerland

16.00 LATAM Accelerated Pan-LATAM Registration Strategy: Ensuring Access Across Argentina, Peru, Columbia & Chile• Industry perspective of the expectations

and regulatory requirements during registration

• Working with your designated authorised representative: Practical regulatory access and registration

• Sharing experiences and strategies for bringing products to market across LATAM countries

• Challenges, opportunities and best practice during the registration process

Mercedes Bayani, Global Vice President for Clinical and Regulatory Affairs, Bioness, United States

Quality and Reliability of Health and Wellness Apps• The challenges faced for appdevelopers to have their app taken up in care pathways• Role of technical specification for app

checkers, repositories, quality and reimbursement frameworks

• Quality and reliability requirementsPetra Hoogendoorn, Owner, National eHealth Living Lab, The Netherlands

INDUSTRY FEEDBACK: Best Practices for Implementing Post Market Surveillance for IVDs under EU IVDR• Displaying what changes wereneeded to ensure IVD compliance• Timelines of requirements forsuccessful Post Market Surveillanceand strategies to meet these• Tips and advice to ensurecompliance• Practical hands on advice for being

compliant with the EU IVDRPäivi Turta, Regulatory Affairs Manager, Medical Devices and In Vitro Diagnostics, Oy Medfiles Ltd, Finland

Strategic Use of Predicate Controls in Medical Device Evaluations The use of predicate controls in the biological evaluation of medical devices including biological evaluation plans, risk assessments and testing can help frame the context of a new device. In testing, the use of predicate controls in traditional evaluations including implantation and hemocompatibility, but also additional ones such as irritation and toxicity, can help normalize and clarify results to best understand the difference between positive and adverse results. Additionally, predicate devices can be used to assess vendor, material or component changes as well asThaddeus Williams, Study Director In-Vivo Biocompatibility, Toxikon

16.30 European Health Data Space: Towards a Better Patient Outcome• Governance and execution• Patient perspective• Potential role of the health data space

for clinical evaluations and for measuring value of digital technologies

Danny Van Roijen, Digital Health Directors, COCIR, Belgium

Latest developments with ISO 10993 – 17• Requirements of ISO 10993 – 17• Updates to the -17 as described in the draft

outline• Timeline for publication of -17• Requirements of QSERVE under – 17• How do I choose the software?• Which modules are available?• Understanding the requirements of

regulatory agencies with QSERVEAlan Hood, Research Toxicologist, FDA, United States

Speed Networking



Drug Device Combination Products EU IVD Regulation and Strategy Biocompatibility for Medical Devices 10:00 - Platform Tutorial

10:10 - Taste of Dublin

10:20 - Opening Remarks

Session Moderated by Session Moderated by Dr Andreas Stange, Vice President MHS Global IVD, TÜV SÜD, Japan

Session Moderated by Jeremy Tinkler, Chairman of ISO/TC 194 (biological and clinical evaluation of medical devices), Director of Regulatory Consultancy and Quality Assurance, MedPass International, UK

10.35 Moving Toward EU MDR Compliance for Commercial Combination Products in the Pharma IndustryModerator:• Gain an overview of Articles 14 and 16• Lessons learned from a post-approval stage product• Key considerations for escalating information – reporting

serious incidents, defects or complaints to the proper authorities

• Packaging and labelling – what should companies take into account to comply with Article 16?

• The challenges of complying with gaining commercial access in the EU, when your company is not based in the EU

Market Surveillance for IVDs• Highlighting the difference between IVDD requirements and

IDVR• Understanding how to satisfy PMS requirementsMarta Carnielli, Senior Manager, Safety Risk Management & Surveillance, TÜV SÜD, Italy

Best practices for dealing with unknowns• Expectations for unknowns • Strategies for dealing with unknowns• Rationalising unknownsNick Edwards, Senior Biosafety Specialist, Ambu, Denmark

11.05 Spotlight Session from Nelson Laboratories UDI Requirements for IVDs• Looking at guidance for UDI and IVDs• Streamlining US and EU UDIs• Incorporating UDI into EU IVDR implementationKarin A. Hughes, Ph.D., Vice President Clinical, Astute Medical, United States

Extractables and Leachables Testing - A Toxicologists Perspective• What does a toxicologist need from the chemist?• What does a chemist need from the toxicologist?• What does a toxicologist do with the data?• Concerns over quality of the dataPhil Clay, Director, ISO TC/194 Member, Chorley Consulting

11.35 Industry Perspective - Regulatory Focus on Device Components Within the New EU Framework• An industry view on EU MDR impact on combination

products• What’s new in the Global Safety and Performance

Requirements (GSPR)• Understand new submissions and substantial changesStephan Affolter, Regulatory + Quality Intelligence Manager, Ypsomed, Switzerland

LDT/ in House Developed Tests Requirements under the IVDR• Article 5.5. of the IVDR: what are the requirements for the

laboratories with the own laboratory developed tests• What to do as a laboratory when an CE IVD test of a

manufacturer is taken of the market and you want to make it an in-house developed test: how to comply to Article 5.5 of the IVD

Anja Wiersma, PhD; CEO, mi-CE consultancy, The Netherlands

Status Update of New Requirements ISO 10993- 23ISO 10993-23 is a new standard expected this fall that will introduce the shift from in vivo to in vitro for the assessment of irritation potential of medical devices. This is a change in mindset for which industry needs to prepare. The convenor of ISO/TC 194/WG 8 and chairman of AFNOR S92/J for the biocompatibility of medical devices will present the scientific reasoning, the added value and the current limits of this new strategyChristian Pellevoisin, Scientific Director, Episkin Academy

AGENDA: DAY 5: FRIDAY 16TH OCTOBER 2020

AGENDA: DAY 5: FRIDAY 16TH OCTOBER 202018 • informaconnect.com/medtech-summit • #MedTech | @MedTechIC



Session Moderated by Session Moderated by Session Moderated by Phil Clay, Director, ISO TC/194 Member, Chorley Consulting

13.20 Regulatory Body - An Update on Combination Products Policy Development in the United StatesModerator:• An overview recent regulatory changes for combination

products • Identify the top policy priorities for FDA’s Office of

Combination Products• Discuss recently issued guidance and regulations as well as

internal FDA changes affecting combination products• Address policy developments from pre-market through post

market, including topics on pathway availability, key review issues such as bridging and human factors, CGMPs and post market safety reporting

John Weiner, Associate Director for Policy, Office of Combination Products, FDA

Preparing for Effective De-Novo submissions• Understanding how the FDA classify novel devices • Industry advice and best practice on submitting De Novo

Requests Sergio de del Castillo, De Novo Program Lead, Office of Device Evaluation, FDA, United States (subject to final confirmation)

Experiences working with the EU MDR and ISO 10993• Comparing 10.4.2 of the EU MDR to the requirements of ISO

10993• How does the requirements translate into reality?• Early experiences working towards EU MDR compliance for

BiocompatibilityKatharina Gruchenberg, Team Leader Biocompatibility and Materials of Animal Origin, TÜV SÜD Product Service GmbH, Germany

13.55 Impact of the EU MDR and ISO 10993-1:2018 on Biological Evaluation of Medical DevicesSophie Clewlow, Higher Medical Device Specialist, MHRA, UK

GLOBAL PANEL DISCUSSION: IVD Regulation• The impact of the EU IVDR globally• How will other CE countries outside of the EU approach re-

registration?• Discussing the harmonisation needed for IVDsAnja Wiersma, PhD; CEO, mi-CE consultancy, The Netherlands Lakshman Prakash Balajepalli, Head of Regulation and Quality, RAS Lifesciences, IndiaJulien Senac, Global Director, IVD Global Focus Team, TÜV SÜD AMERICA, United States

Impact of the EU MDR and ISO 10993-1:2018 on Biological Evaluation of Medical DevicesSophie Clewlow, Higher Medical Device Specialist, MHRA, UK

14.30 - Break – A chance to connect with stakeholder, sponsors and fellow attendees

Session Moderated by Session Moderated by Session Moderated by Charlotte Laupheimer, Preclinical Research Manager & Medical Writer, Geistlich Pharma AG, Switzerland

19 • informaconnect.com/medtech-summit • #MedTech | @MedTechIC AGENDA: DAY 5: FRIDAY 16TH OCTOBER 2020


15.35 Biocompatibility Evaluation Requirements of Combination ProductsModerator:• An overview of biological risk evaluation assessments of

combination products• Learn how to perform biocompatibility testing according to

ISO 10993• Case study in the selection an appropriate test strategy to

address biocompatibility endpoints Chris Parker, Associate Department Head, In-Vivo Biocompatibility, Toxikon, United States

Dual Dialogue: Classification of In Vitro Diagnostics in Europe & The United States• Clarifying the differences in European & US classifications• Juggling intended use vs intended purpose statements • Understanding how to adapt your project strategy to run

across both regionsJulien Senac, Global Director, IVD Global Focus Team, TÜV SÜD AMERICA, United States

Recent FDA biocompatibility feedback from 510k submissionsSubmitting for an approval for a medical device through the FDA can be a stressful and anxious time. It is important to understand the most recent recommendations from the agency. Too often these recommendations are given through feedback from the submission process itself, making a proactive approach difficult. In this presentation we will review recent FDA suggestions from real 510k submissions. These suggestions will touch on all aspects of the ISO 10993 standard series from cytotoxicity, sample preparation, E&L, toxicology, and more.

16.05 Constructing a Strong End-To-End Development Programme for Injectable Combination Products• Overview of practical drug-device combination product

development steps to assure justification for regulatory inquiries

• Best practices for risk-based testing using an iterative development approach

• Discussion of the approach for identification of Essential Performance Requirements (EPRs)

• Understanding the importance of the interrelationship among components, process, device and drug in understanding combination products

Fran DeGrazio, Chief Scientific Officer, West Pharmaceutical Services, United States

Understanding Labelling Requirements Under the EU IVDR• Clarifying labelling regulations for intended use vs intended

purpose• Guidance on harmonised labels and meeting requirementsKarin A. Hughes, Ph.D., Vice President Clinical, AstuteMedical, United States

Experiences working with global submission: Current status and next steps? • State of the art vs EU harmonised standard vs FDA

recognised consensus standards• New products vs. released products changes• Lessons learned and technical recommendations towards

global approvalSiyi Zhang, Principal Chemist, Applied Chemistry Lab, Restorative Therapies Group, Medtronic, United StatesSharlene Dai, Distinguished Toxicologist, Neuro Therapy Delivery System, Restorative Therapies Group, Medtronic, United States

16.35 A Spotlight on Post-Market Safety Reporting• Discuss the challenges and solutions faced by the industry

in a global environment• Key considerations for streamlining compliance for drug-

device products• Address the roles and responsibilities for a risk-based

approach to PMSR decision-makingKhaudeja Bano, Sr. Medical Director, Abbott Diagnostics Division, Abbott Diagnostics, United States

17.00 - Close of Conference

20 • informaconnect.com/medtech-summit • #MedTech | @MedTechIC AGENDA: DAY 5: FRIDAY 16TH OCTOBER 2020


21

TRAINING COURSE: Medical Device Regulatory Project Management27-30 October 2020 | 4 Day Course | 14.00 – 17.00 each day

UPSKILL THIS OCTOBER WITH A TRAINING COURSE…

TUESDAY 27TH OCTOBER14.00 – 17.00Session OneIntroduction to Project Management• Early development stages in a project:

- Timelines and considerations on the device life cycle

- Capturing the value proposition- Early validation through feasibility studies

• Planning and initiating the project- Regulatory strategy- Assigning roles and responsibilities in-

house and across boundaries- Team communication, collaboration and

leadership- Document and records management, logs

and traceability

FRIDAY 30TH OCTOBER14.00 – 17.00Session FourManaging Medical Device Project Cycles• Product life cycle thinking: Does the project

have an end?• Design Control as the middle cycle: The

typical project cycle- Design Inputs, Outputs, Verification,

Validation, Process Validation, Transfer, Changes and Reviews

• The micro cycles of project management: The daily work- Plan-Do-Check-Act / Build-Validate-Learn /

Agile methodologies• Maintaining alignment and adapting to

change- Post market activities – surveillance and

clinical follow-up- Corrective and preventive actions and

methods- Project metrics

Course Feedback Session Delegates will get the opportunity to finish the course by asking any remaining questions and queries regarding the course content and the simulation exercises.

THURSDAY 29TH OCTOBER14.00 – 17.00Session ThreeA Closer Look at Clinical Evaluation in a Project• The importance of conducting a literature

review• Clinical investigations, sufficient clinical

evidence and post-market activities• Transitioning from the current to new clinical

evaluation requirements (MDR)• Case Study on how to conduct a clinical

evaluation plan in accordance with regulations

Applying Risk Management in a Project• Risk management practicalities- ISO 14971 and Design FMEA (Failure Modes &

Effects Analysis)- Biocompatibility (ISO 10993 series)- Electrical safety (IEC 60601 series)- Software life cycle (IEC 62304)- Usability (IEC 62366)• Benefit-risk analysis as the final outcome • Case Study on how to conduct a risk

management plan and risk assessment in accordance with regulations

WEDNESDAY 28TH OCTOBER14.00 – 17.00Session TwoApplying Regulatory Requirements to Project Management• The role of global regulations and standards

in medical device project management• Key regulatory considerations throughout the

medical device lifecycle:- General Safety and Performance

Requirements- Clinical Evaluation- Risk Management

• Design Control requirements in project management

• Other regulatory considerations for project management:- Quality system requirements (ISO 13485,

FDA QSR)- Vendor control- Labelling and instructions for use

Managing Regulatory Changes and Communicating with Authorities• Navigating the transitional periods of the

changing global legislations through strategic regulatory planning, including:- MDD to MDR- IVDD to IVDR

• Communication and timelines with authorities, laboratories and certification bodies- Product testing and certification against

international standards- Audits and technical file reviews

• Case Study for dealing with a variety of requirements and changing legislative timelines in a project

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