webinar: how to get localization and testing for medical devices done right
TRANSCRIPT
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 – [email protected]
Nausheen Sayed [email protected]
www.QualiTestGroup.com
Thank You!