medical devices - industries | ul · pdf fileconcept, design, and development phases to avoid...
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HFE & Usability Testing
Non-Clinical & Analytical Testing
Risk Management
Interoperability & e-Health
Product &Process
Validation
QualitySystem
Registration & Support
ClinicalInvestigation
Training &Compliance
Global Regulatory
Advisory
Registration &File Construction
Full Support During the Product Development and LifeCycle
MEDICAL DEVICESComprehensive Lifecycle Services to Support Regulatory Approvals
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There are many risks involved with placing medical devices on the market. As an independent and trusted 3rd party, UL helps manage, reduce, or mitigate risks so companies can focus on their core competencies of designing, manufacturing, marketing, and selling their products. With global expertise and expanding capabilities, we provide this support throughout the product lifecycle.
Comprehensive Lifecycle Services to Support Regulatory Approvals
Product: Product risk is a very tangible reality for the medical industry. The risks extend to product usability, safety and even to safe interoperability with other devices. UL provides risk mitigation through testing, validation, supplier management through vendor and component inspections, responsible sourcing and RoHS compliance.
Regulatory Approvals:The risks in gaining and maintaining regulatory approvals has its own unique risks. The first risk is getting the approval. UL provides the advantage of years of experience working with regulators to help manufacturers with regulatory technical documentation and regulatory submissions support. We also help demonstrate regulatory compliance post-market through mock audits, quality management approvals, and post-market support.
Safety testing
EMC
Unique Device Identifier (UDI) compliance
Usability/HFE
Interoperability testing
Non-Clinical Testing
Clinical investigation
Risk Management
Software
Wireless
Technical Documentation preparation
Mock audits to regulatory requirements
Submission services
Remediation support
Third Party Regulatory Approvals:
Japan PAL Brazil INMETRO
EU CE Mark Canada CMDCAS
RISK SERVICES
Business:Potential risks to the business extend to the company brand, reputation and ability for all suppliers and affiliated representatives to comply with global standards of business conduct.
Robust, FDA regulatory learning management systems that can be adapted to meet Notified Body, and other country regulatory requirements
Training modules, systems and seminars to give your global staff a consistent understanding of the requirements and fulfill regulatory training needs
Compliance management systems to support key application and consistency to minimize your business risk with a global sales and supply chain
From idea to post-market
Supply chain services to verify your component and materials suppliers and vendors to your criteria
WORKING WITH UL TO HELP MITIGATE YOUR GLOBAL RISKS
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Human Factors Engineering, including User Interface Design Support and Usability Testing
Non-Clinical & Analytical Testing
Quality System Registration & Support
Training & Compliance
Interoperability & e-Health
Risk Management
Product & Process Validation
Supply Chain Services
Global Regulatory Advisory
Registration & File Construction
Clinical Investigation
Idea
DefineRequirements
BasicResearch
R/D
Prototype
PreclinicalBiocomp.
ClinicalTrials
Final Device
RegulatorySubmissions Commercial
Launch Post Market
MEDICAL D
EVICE PRODUCT DEVELOPMENT: PATH TO COMMERCIALIZATION
Human Factors Engineering, including User Interface Design Support and Usability Testing
Non-Clinical & Analytical Testing
Quality System Registration & Support
Training & Compliance
Interoperability & e-Health
Risk Management
Product & Process Validation
Supply Chain Services
Global Regulatory Advisory
Registration & File Construction
Clinical Investigation
Idea
DefineRequirements
BasicResearch
R/D
Prototype
PreclinicalBiocomp.
ClinicalTrials
Final Device
RegulatorySubmissions Commercial
Launch Post Market
MEDICAL D
EVICE PRODUCT DEVELOPMENT: PATH TO COMMERCIALIZATION
FuLL SuPPoRT DuRing PRoDuCT DeveLoPmenT AnD LiFeCyCLe
Integrated Safety Certification Assessment
REGULATORY SUBMISSIONS WITH UL
YOUR TECHNICAL FILE
Integrated Quality & Management Systems Assessment
Pre-Clinical Analytical Testing & Verification Services
• CSA C22.2 No. 601.1 Canada requirements• EMC – IEC 60601-1-2• ANSI/UL 60601 US requirements• CB Scheme “MED”• NBR IEC 60601-1 Brazil requirements• EN 60601 EU requirements• JIS 60601 Japan requirements> Base Standard: IEC 60601-X-X
• ISO 13485• FDA QSR• JapanMO No. 169• ISO 13485 under CMDCAS• EU Annexes under MDD and IVDD• ISO 14971> Base Standard: ISO 13485
• Biocompatibility – ISO 10993, USP• Sterility – ISO 11137• Packaging – ISO 11607• Physico-chemical• Clinical investigations using ISO 14155> And other applicable standards
CanadianRegulatoryApprovals
Regulatory Approvalsfor global emerging markets
FDAApprovals
ChineseApprovals
JapaneseRegulatoryApprovals
BrazilianApprovals
European UnionRegulatoryApprovals
With integrated assessments,UL gives you the data to supportmultiple regulatory submissions and can help you with learning
management, technical file preparation, advisory services
and submission.
UL provides comprehensive services to support medical and IVD companies with global regulatory submissions. Our local services include integrated systems registrations for ISO 13485, Canada CMDCAS, European Notified Body, Japan – PAL, Brazil – INMETRO and Risk Management ISO 14971. Our experienced engineers provide safety assessments to IEC 60601, IEC 61010, Home-Healthcare and CB Scheme. Our Human Factors Engineering experts provide design support and validation testing. Our team can also support your Regulatory and Learning Management Systems through ComplianceWire®, online and in person training.
UL also conducts non-clinical tests including sterility, shelf-life, transport and packaging validation and biocompatibility.
UL experts are on the leading edge of supporting customers with global regulatory submissions documentation, clinical evaluation, advisory and support including evolving regulatory advisory and testing services for eHealth mobile medical applications and interoperability.
Find out more: www.ul.com/medical
A comprehensive, start-to-finish program that moves your product through global approvals.
INTEGRATED ASSESSMENTS TO ACCESS GLOBAL MARKETS
Comprehensive Lifecycle Services to Support Regulatory Approvals
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HumAn FACToRS engineeRing (HFe)
Support during Product Development
UL can assess your product’s interactive quality and conformance with FDA’s HFE Guidance and IEC 62366
Summative and Formative HFE assessments
Help you establish an HFE program – an essential step for all medical companies.
UL’s HFE 30+ expert team members, based in multiple countries, have written HFE textbooks and standards, teach at prestigious universities, and hold multiple design patents.
www.wiklundrd.com
PRe-CLiniCAL TeSTing FoR meDiCAL DeviCeS
Biocompatibility testing
ISO 10993, USP, MHLW
Materials Characterization
Microbiological testing
Virological testing
Cleaning, Reprocessing, Sterilization
Physico-Chemical analysis
Shelf Life of devices and packages
Transport safety
Testing of ophthalmic devices
www.ul-mdt.com
eARLy engAgemenTPrograms to help you make certification decisions early in the design process
Many flexible programs available:
Technical Assistance Program
“Office Hours”
Preliminary Investigations
Gap Assessments
Proactive Review with assigned engineer
Optimized timing for value-added engineering during the concept, design, and development phases to avoid costly re-work later in pre-production.
SAFeTy TRAining & CeRTiFiCATionA Blended Approach: Integrated test plans to meet requirements in multiple countries.
Combined safety: UL, cUL, CB, JIS, INMETRO, EN, Canada
60601 2nd & 3rd editions, Amendment 1 plus ISO 14971 Risk Management and Software
61010 2nd & 3rd editions
Data Acceptance Programs – many options
Multiple CBTL locations worldwide
#1 issuer of CB’s for MED
CB combined with UL Mark for streamlined global access
COMPREHENSIVE SERVICES
Comprehensive Lifecycle Services to Support Regulatory Approvals
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Comprehensive Lifecycle Services to Support Regulatory Approvals
CLiniCAL CRo SeRviCeSClinical Investigations and multinational studies – Full Compliance with GLP and ISO/IEC 17025
Clinical trial support includes:
Project Management – Requirements, timelines, coordination of study sites/investigators, study activities and info flow across parties.
Monitoring & Quality Assurance – Site visits, source data verification, support of investigators.
Medical Writing – Documentation across all clinical activities, patient info/consent forms, investigation plan/protocol, final integrated clinical report.
RoHS 2 SeRviCeS FoR meDiCAL AnD LAB eQuiPmenTSupport to meet EU and global environmental regulations
Training
Gap Analysis
Bill of Materials Scrub
Analytical Testing
Ongoing Assessments for due diligence
Documentation preparation
IDES material information database
QuALiTy mAnAgemenT SySTemS
ISO Registrar – ISO13485, CMDCAS, ISO14971, audit consolidation
CE Notified Body – MDD, IVDD, new regulations, local/regional auditors
Global Footprint – One calibrated medical team
Combined Audits – JGMP, 13485/CMDCAS, CE, 14971, FUS, DAP
Risk Management – Options to support 3rd ed 60601-1
Transfer to UL – Streamlined transfer (including label transfer options)
Supply Chain Verification Services
eHeALTH AnD moBiLe HeALTH
Advisory – Global regulatory strategy and planning
FDA submission support
Education and Private Workshops:
• EMC, Wireless Co-Existence Testing, and Interoperability
• Security, Data Integrity, and Quality of Service (QoS)
Assistance with Mobile Medical Applications
Continua Alliance (CA) Testing
Wireless Services
Software-only medical devices
Medical Device/Systems Software and System Safety
Continua certified test lab
GLOBAL SUPPORT
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CanadaISO 13485 under CMDCAS
Testing and classification to Canadian safety standards - CSA C22.2 No 61010 and CSA C22.2 No. 60601
Quality system support and prevention for ISO 13485 under CMDCAS CMDR
BrazilTesting to Brazil safety standards NBR/IEC 60601 and IEC 61010
INMETRO certification
China, Taiwan, KoreaApplication services approvals for regulatory advisory services
Taiwan technical cooperation program
JapanTesting and certification to JIS standards:
60601
PAL 3rd party approvals for class 2 designated controlled devices
ISO 13485 under JGMP Ministerial Ordinance 169
Non-Clinical Testing:
Biocompatibility, packaging validation, 3 shelf life studies, materials characterization, transportation testing
EMC testing
european union Clinical Evaluation
RoHS II Directive compliance support services
Dedicated web page for IEC 60601 3rd edition transition
CE Marking Notified Body under MDD and IVDD
ISO 13485 medical quality system registration
CB Scheme test certificates and informative reports
Non-Clinical Testing Biocompatibility, packaging validation, shelf life studies, materials characterization
EMC testing
UL-EU mark
GS mark
D mark
Home healthcare
Infusion pump performance testing to support NB submissions
Own brand labeling for Notified Body
Human Factors Engineering and Usability to support Notified Body submissions for CE-Mark
Clinical Investigations, CRO, ISO 14155
Quality system support and prevention for ISO 13485 under EU Medical Device Regulations
Additional Services to Support global Regulatory Submissions CB informative test report
Global market access
Instructor led training
On demand learning and webinars
ISO 13485 medical quality system registration
EMC testing and SAR testing
ISO 14971 risk management registration
Testing to meet country specific requirements
Infusion pump performance testing to IEC 60601-2-24 particular standard requirements
Assessments to IEC 60601-1-6 (Usability) and ISO 62366 for global regulatory submissions
Award winning ComplianceWire regulatory learning management system
Human Factors user interface and user documentation design support
Supply Chain Verification Assessment Services
SeRviCeS By CounTRyunited States UL classification under IEC/UL 60601
EMC testing for FCC and 60601-1-2
Non-Clinical Testing Biocompatibility, packaging validation, shelf life studies, materials characterization
Home healthcare
Infusion pump performance testing to support FDA submissions
Human Factors Engineering and Usability to support FDA submissions
Clinical Investigations, CRO
FDA QSR – 21 CFR 820 Mock audits, audit preparation and gap assessments
MDR Filing
UDI labeling advisory and support
Form 483 and warning letter response
CDRH Radiation submission support – FDA CFR 1000-1020 and IEC 60825
Validation of 21 CFR Part 11
510(k) PreMarket Notification gap analysis, preparation and submission and biocompatibility test plan development
Risk management ISO 14971
Software validation and documentation review
Assess compliance with Usability IEC 62366 and FDA’s HFE Guidance
Clinical trial support for FDA cGMP (CRO)
Test
meDiCAL ReguLAToRy ADviSoRy SeRviCeS FoR gLoBAL mARKeT ACCeSS
FDA 510(k) Preparation and Registration Services
Global Regulatory Quality System Support & Prevention
FDA Inspection Support & Remediation
Global Regulatory Technical File Gap Analysis, Preparation & Submission
Global Regulatory Registration Support
Test Plan Development
Human Factors Engineering / Usability Design Support
Clinical Evaluation
Environmental Support Services
Unique Device Identification Support
www.ulmedicaladvisory.com
uL eDuneeRing – QuALiTy, ComPLiAnCe, LeARningComplianceWire® – A regulatory based learning management system (LMS): an all in-one role based training solution & SOP/document control system
Cloud-based 21CFR & Annex 11-validated LMS System
FDA and AdvaMed content – Unique CRADA with FDA: 36,000 FDA investigators trained on ComplianceWire.
Standardized training & qualification across your organization – Role-based programs, minimize risk and improve quality and business performance.
Online Tools – Ensure SOPs and other policies are being followed and identify “high risk” employees
Online records to streamline audit preparation
www.uleduneering.com
BrandonHallA W A R D S
Technology 2013
E X C E L L E N C E
– 5X Winner –Best Advance in Learning Management Technology
for Compliance Training
Canada:Health Canada
CMDR
Regulatory approvals forglobal emerging markets
United States:FDA
China:CFDA
Brazil:INMETRO
and ANVISA
Korea:MFDS
European Union:IVD/MDD
north [email protected]
South [email protected]
Asia and [email protected]
Comprehensive Lifecycle Services to Support Regulatory Approvals
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ul.com/medical
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EUROPE
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ASIA PACIFIC
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