webinar: how to get localization and testing for medical devices done right

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How to get localization and testing for medical devices done right

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Page 1: Webinar: How to get localization and testing for medical devices done right

How to get localization and testing for medical devices done right

Page 2: Webinar: How to get localization and testing for medical devices done right

Webinar Presenters

Nausheen SayedVP Knowledge and Innovation US-

UK

David SommerDirector of Strategic Operations

Page 3: Webinar: How to get localization and testing for medical devices done right

Agenda

Challenges Lessons Learned

Introduction

Summary Solutions and Tools Q &A

Page 4: Webinar: How to get localization and testing for medical devices done right

Agenda

Challenges Lessons Learned

Summary

Introduction

Solutions and Tools Q & A

Page 5: Webinar: How to get localization and testing for medical devices done right

About QualiTest Group

| World’s 2nd Largest Independent Testing Company

| QualiTest recognized for each of the past 3 years as the only visionary pure play QA and Testing Services Company in the “ Magic Quadrant”

Page 6: Webinar: How to get localization and testing for medical devices done right

Domain background

| The Medical and Healthcare domain can be a vast playgroundto offer testing services

| At QualiTest, we offer a variety of testing services that comply with FDA regulations

| Some of our clients including Fujifilm, GE Healthcare, Philips, Carl Zeiss, THINK Surgical and Accuray

| For more info visit our website

Page 7: Webinar: How to get localization and testing for medical devices done right

About Net-Translators

| Global Multilingual Localization Provider| Est: 2001| Coverage & Solutions:

| Over 60 languages| Solution oriented provider of language and technology solutions

| Certifications:| ISO 9001:2008, ISO 13485:2003, ISO 17100:2015-05 and

CAN/CGSB-131.10-2008

| Major Locations:| United States, Israel, Argentina

Page 8: Webinar: How to get localization and testing for medical devices done right

Agenda

Challenges Lessons learned

Summary

Introduction

Solutions and Tools Q & A

Page 9: Webinar: How to get localization and testing for medical devices done right

Medical Device Testing and Localization

| Domain knowledge| FDA rules and regulations| Sensitive Client environment | Test Data–management, compatibility, standards like DICOM| Flexible, light Test tools for every stage:

design, development and V&V| Compatibility testing| Localization testing

Challenges

Page 10: Webinar: How to get localization and testing for medical devices done right

EU Language Requirements for MDD

| Requirements to translate safety related materials| Manufacturer ultimately responsible for translation| Medical Device Directive 93/42/EEC article 4.4:

| Annex I, point 13• labels and display, safety instructions and instructions for use

| In-Vitro Diagnostic Directive 98/79/EC article 4.4

Page 11: Webinar: How to get localization and testing for medical devices done right

Agenda

Challenges Lessons Learned

Q&ASummary

Introduction

Solutions and Tools

Page 12: Webinar: How to get localization and testing for medical devices done right

Lessons learned

Some of our case studies and experience indicate:

| Domain knowledge and training - very essential| Effective engagement models| Test Data - very critical, saves time and money if done right| Nativity and fluency in language of engineers for

localization testing| Right selection of tools

Page 13: Webinar: How to get localization and testing for medical devices done right

ISO 17100:2015 Translation Standard

| Translation services - Requirements for translation services| Resources:• Human • Competencies and Qualifications • Technical

| Pre-production processes and activities:• Feasibility• Quote• Project and client specific information• Project preparation

| Production process:• Project Management • Process

Page 14: Webinar: How to get localization and testing for medical devices done right

ISO 17100:2015 Translation Standard

| Production process| Project Management | Process:• Translation• Check• Revision• Review• Proofreading• Final verification and delivery

| Post-production processes| Feedback| Closing

| Confidentiality

Page 15: Webinar: How to get localization and testing for medical devices done right

Agenda

Challenges Lessons learned

Q & ASummary Solutions and Tools

Introduction

Page 16: Webinar: How to get localization and testing for medical devices done right

Solutions and Tools

| What to automate?| Regression tests, memory leaks, memory consumption,

input fields testing

| How to automate?| Automation tool selection• Revision control and document tracking • Analysis and reporting• Learning curve for tool and maintainability in future• Costs and ROI•Mutli threading

| Data driven frameworks| Pseudo code generation

Page 17: Webinar: How to get localization and testing for medical devices done right

Test Case Pseudo Code Eggplant Functions

1) DMS Record Test Environment.

2) Launch System Administration Launch System Administration. Func_OpenProcessFromHomeScreen

3) Click the DICOM Hosts Tab From the System Administration, click on the DICOM Hosts tab. Func_ClickImage

4) Select the + icon to create a New DICOM Host Click on the + button to create a new host. Func_ClickImage

5) Enter Host Name

Type the new host name. Func_AddNewHost

6) Enter AE Title

Type the AE Title Func_AETitle

7) Enter IP Address Type the IP Address Func_IPAddress

Test Script 14423 DICOM:Destination Configuration

Page 18: Webinar: How to get localization and testing for medical devices done right

Virtual Radiology EnvironmentTool

| Qualitest‘s Virtual Radiology Environment (VRE) is a comprehensive testing solution, aimed to test your Picture Archive Communication Systems (PACS) for scalability and reliability, delivering a comprehensive turnkey solution for synchronized Digital Imaging and Communications in Medicine (DICOM) and Health Level 7 (HL7) Traffic

| VRE is a simulation system that provides all of the network patterns and data flow that occur natively in the Radiology domain

| VRE effectively reduces time, personnel needs, and a substantial Return on Investment (ROI) without sacrificing accuracy or reproducibility

Page 19: Webinar: How to get localization and testing for medical devices done right

Case study on VRE

| Client Overview and Business Need:| The client is a diversified technology company with primary divisions

focused in the areas of healthcare, consumer lifestyle and lighting| The main issue was managing the memory for a client viewer while

updating and processing of DICOM images of a given modality, size and slice count

| QualiTest Solution:| We proposed the VRE tool and performed a free-of-charge Proof of

Concept, demonstrating the benefits and assuring quality and interoperability while simplifying and dramatically speeding-up all aspects of V&V testing

| Key Benefits| VRE reduced testing time by 33%| VRE reduced personnel needs by 90%| The paperwork and coordination for executing such a task were greatly

simplified

Page 20: Webinar: How to get localization and testing for medical devices done right

Application Strings User Documentation

Help Desk

Digital Content

Process Strategy

Web

Marketing Content

prepare

translate

QC

return

extract

Page 21: Webinar: How to get localization and testing for medical devices done right

Key Parts of the Process

| Content review| Terminology management

| Glossary creation | Glossary translation

| Training| Translation, editing and proofreading| Post process

| DTP| Testing| In-context checks| Final review

Page 22: Webinar: How to get localization and testing for medical devices done right

Industry Tools

| Computer Assisted Translation tools (CAT) | SDL Trados Studio| SDL Passolo| XTM

| Translation Platforms| Net-Proxy| Net-Cloud

| Desktop Publishing| Adobe| Articulate| Microsoft| Single Source| DITA

Page 23: Webinar: How to get localization and testing for medical devices done right

Agenda

Challenges Lessons learned

Q & ASummary Solutions and Tools

Introduction

Page 24: Webinar: How to get localization and testing for medical devices done right

| Are you keeping up with the domain knowledge?

| Are you using the right tools to replicate a live environment?

| Are you automating efficiently?

| How are you engaging with your testing teams?

| Are you managing your risks or exposure?

Summary

Page 25: Webinar: How to get localization and testing for medical devices done right

Agenda

Challenges Lessons learned

Q & ASummarySolutions and Tools

Introduction

Page 27: Webinar: How to get localization and testing for medical devices done right

www.QualiTestGroup.com

Thank You!