The document discusses approaches for safe medical software development, emphasizing the integration of product risk management into various processes within the medical device development lifecycle. It outlines challenges with heterogeneous tooling and the need for effective process control and transparency in design. Additionally, it introduces Intland Software's validated process templates for customizing medical software engineering practices.

1. 21/10/2020
Enabling Safe Medical Software
Development through a Purpose-
built Toolchain
Szabolcs Agai
Functional safety and quality expert

2. 2
Agenda
• MedTech development
• Safe medical software development

3. 3ANNUAL USER CONFERENCE 2020
MedTech Development
Innovation
Research
Development
Production

4. 4ANNUAL USER CONFERENCE 2020
MedTech development
Challenging environment
Time Resources
Design Safety &
Design Quality
Medical device
design and development

5. 5ANNUAL USER CONFERENCE 2020
MedTech development
Regulated environment
Market regulations
Harmonized, recognized standards
Manufacturer’s QMS Customer’s QMS Engineering practices
Market / Customer
expectations
Organizational
goals
Medical device
design and development

6. 6ANNUAL USER CONFERENCE 2020
MedTech development
Internal environment
Engineering team Quality and regulatory team

7. 7ANNUAL USER CONFERENCE 2020
MedTech development
Process environment
Key Processes
Requirement
engineering
Verification and
validation
Clinic validation Market approval
Design control
management
Electronic content
management
Audit management CAPA management
Customer complaint
management
Management review
Product Risk
Management
Configuration and
change management

8. 8ANNUAL USER CONFERENCE 2020
MedTech development
Tooling environment
Task Management
Document sharing
Requirements Management
QMS
Documents
Management
Wiki
MS Word

9. 9ANNUAL USER CONFERENCE 2020
MedTech development
Heterogeneous tooling challenges
Data
Data
Data
Data
Data
Data
Data
Data
Data
Data
Data
Data
Data
Data
Data
Data
Data
Timely
Information

10. 10ANNUAL USER CONFERENCE 2020
MedTech development
Heterogeneous tooling challenges
• How to enable transparency in design processes
• How to maintain process control
• How to move from documents to intelligent content management
• How to integrate with Product Risk Management

11. 11ANNUAL USER CONFERENCE 2020
Safe medical software development
Why deal with Product Risk Management
Random Systematic
• Errors are a fact of life – they were alway with us, and are here to stay.
• Types of errors:

12. 12ANNUAL USER CONFERENCE 2020
Safe medical software development
Why deal with Product Risk Management
Random
hardware errors
Systematic
errors
• We can calculate,
estimate, and plan for
failures
• Control:
• FMEA, DFMEA, PFMEA,
FMEDA and others
• ISO 60601 series
Systematic process errors
(SW & HW Designs)
Control:
ISO 13485
ISO 14971
ISO 62304/82304 and
others

13. 13ANNUAL USER CONFERENCE 2020
Safe medical software development
How to deal with Product Risk Management

14. 14ANNUAL USER CONFERENCE 2020
Safe medical software development
Standardization for Product Risk Management

15. 15ANNUAL USER CONFERENCE 2020
Safe medical software development
How to integrate Product Risk Management
Processes
Methods
Practices
Roles
Activities
Stages
Collaborative
workflows
Work
products
Roles
Activities
Stages
Intelligent
design contents

16. 16ANNUAL USER CONFERENCE 2020
Safe medical software development
How to integrate Product Risk Management
Process
Group
Process
Workflows
Process Definition
Work
Products
Roles RACI
Contents

17. 17ANNUAL USER CONFERENCE 2020
Safe medical software development
How to integrate Product Risk Management

18. 18ANNUAL USER CONFERENCE 2020
Safe medical software development
How to integrate Product Risk Management

19. 19ANNUAL USER CONFERENCE 2020
Safe medical software development
How to integrate Product Risk Management
0
Medical QMS Process framework
Good engineering practices

20. 20ANNUAL USER CONFERENCE 2020
Safe medical software development
How to integrate Product Risk Management
0

21. 21ANNUAL USER CONFERENCE 2020
Safe medical software development
How to integrate Product Risk Management
• R&D Manager
• Product manager
• Development lead
• Clinic fellow
• Product risk analyst
• Architect
• Requirement engineer
• Software developer
• Verification and
validation engineer
• etc.
• Medical software
development planning
• Change Management
• System design and product
risk management
• Requirement engineering
• Lifecycle product risk
management
• Verification and Validation
• Documentation
management
• Software of unknown
provenance management
• Legacy software
management
• etc.
• User Requirement Specification
• System Requirement
• System Architecture
• Risk Analysis and Evaluation
• Risk Control
• System Product Risk
Requirements/Mitigation
• Software Requirements
• Software Architecture
• Software Design Specification
• System validation protocol
• SW/HW integration protocol
• Software integration protocol
• Software unit verification protocol
• Test reports
• etc.
User roles Workflows Trackers

22. 22ANNUAL USER CONFERENCE 2020
Safe medical software development
How to integrate Product Risk Management
Source code management (SVN, GIT, etc.)
Automated test environment (Jenkins)
Legacy task management (JIRA)
Specialized tooling (DFMEA, PFMEA, etc.)

23. 23ANNUAL USER CONFERENCE 2020
Safe medical software development
Intland Software’s approach
Validated,
pre-built
process templates
• Medical Software Engineering
• Medical Audit and
CAPA management
Custom tailoring Full customization

24. 24ANNUAL USER CONFERENCE 2020
Safe medical software development
Medical Software Engineering Template
• R&D Manager
• Product manager
• Development lead
• Clinic fellow
• Product risk analyst
• Architect
• Requirement engineer
• Software developer
• Verification and
validation engineer
• etc.
• Medical software
development planning
• Change Management
• System design and product
risk management
• Requirement engineering
• Lifecycle product risk
management
• Verification and Validation
• Documentation
management
• Software of unknown
provenance management
• Legacy software
management
• etc.
• User Requirement Specification
• System Requirement
• System Architecture
• Risk Analysis and Evaluation
• Risk Control
• System Product Risk
Requirements/Mitigation
• Software Requirements
• Software Architecture
• Software Design Specification
• System validation protocol
• SW/HW integration protocol
• Software integration protocol
• Software unit verification protocol
• Test reports
• etc.
User roles Workflows Trackers
Preconfigured

25. 25ANNUAL USER CONFERENCE 2020
Safe medical software development
Medical Software Engineering Template
Preconfigured

26. 26ANNUAL USER CONFERENCE 2020
Safe medical software development
Medical Software Engineering Template

27. 27ANNUAL USER CONFERENCE 2020
Safe medical software development
Medical Software Engineering Template

28. 28ANNUAL USER CONFERENCE 2020
Safe medical software development
Medical Software Engineering Template

29. 29ANNUAL USER CONFERENCE 2020
Safe medical software development
Medical Software Engineering Template

30. 30ANNUAL USER CONFERENCE 2020
Safe medical software development
Medical Software Engineering Template

31. 31ANNUAL USER CONFERENCE 2020
Safe medical software development
Quick outlook: Medical Audit and CAPA Management Template

32. Thank you!