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

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

Agenda

Challenges Lessons Learned

Introduction

Summary Solutions and Tools Q &A

Agenda

Challenges Lessons Learned

Summary

Introduction

Solutions and Tools Q & A

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”

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

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

Agenda

Challenges Lessons learned

Summary

Introduction

Solutions and Tools Q & A

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

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

Agenda

Challenges Lessons Learned

Q&ASummary

Introduction

Solutions and Tools

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

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

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

Agenda

Challenges Lessons learned

Q & ASummary Solutions and Tools

Introduction

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

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

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

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

Application Strings User Documentation

Help Desk

Digital Content

Process Strategy

Web

Marketing Content

prepare

translate

QC

return

extract

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

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

Agenda

Challenges Lessons learned

Q & ASummary Solutions and Tools

Introduction

| 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

Agenda

Challenges Lessons learned

Q & ASummarySolutions and Tools

Introduction

David Sommer – david.sommer@net-translators.com

Nausheen Sayed -nsayed@qualitestgroup.com

www.QualiTestGroup.com

Thank You!