The document discusses an integrated ALM and eQMS platform called Intland Retina that aims to align quality management systems and engineering processes for medical product development. It provides pre-built process templates that support medical device software development and audit/CAPA management according to FDA and EU regulations. The templates include roles, workflows, data containers and a logical data model to provide traceability, risk management and documentation compliance for the medical device development lifecycle. Intland Retina is presented as offering a standardized yet customizable solution to streamline quality and engineering tasks.

1. 23/10/2019
Aligning QMS and Engineering
Processes in Medical Product
Development
Szabolcs Agai, Quality and Regulatory Expert
Intland Professional Services

2. 2
Overview
• When QMS meets
Medical Software Engineering
• Current practices and challenges
• Typical use cases across
medical compliance
• A brand new solution
for easy and fast adoption

3. 3
• Company founded in 1998,
HQ in Stuttgart, Germany
• Active in safety-critical markets
for over 10 years
• Products and processes
certified by TÜV Nord and TÜV Süd
Who we are
Intland Software &
Medical Device Developers

4. 4
QMS meets ALM
Integrated platform for Engineering and QAR teams
Engineering team Quality and regulatory team

5. 5
Current Practices and Challenges
Point solutions
Task Management
Document sharing
Requirements Management
QMS
Documents
Management
Wiki
MS Word

6. 6
Compliance
Current Practices and Challenges

7. 7
Intland Retina
Integrated ALM + eQMS platform
0
Medical QMS Process framework
Good engineering practices

8. 8
1. ALM and eQMS
for MedTech Engineers
2. Designed and validated
by industry experts
3. Easy to use,
intuitive user interface
4. Highly configurable,
flexible to your processes
5. Guaranteed
and automatic traceability

9. 9
Intland Retina
Values
Focus on patient safety
Save time to
deliver safe and best in class device
Minimize the burden
of dealing with administrative tasks
Deliver consistent design content
for regulatory purposes

10. 10
Intland Retina
Process approach
Validated,
pre-built
process templates
• Medical Software Engineering
• Medical Audit
and CAPA management
Custom tailoring • Additional and Custom Use Cases

11. 11
Our Medical Templates
support the development of
US FDA:
Software as a Medical Device (SaMD)
EU:
Medical Device Software (MDSW)

12. 12
Medical Software Engineering Template
Key supported processes

13. 13
Medical Software Engineering Template
Foundation
• 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 Data containers

14. 14
Medical Software Engineering Template
Foundation
• 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 Data containers
Preconfigured

15. 15
Medical Software Engineering Template
Logical Data Model

16. 16
Medical Software Engineering Template
Information synthesis
Data
Data
Data
Data
Data
Data
Data
Data
Data
Data
Data
Data
Data
Information

17. 17
Medical Software Engineering Template
Information synthesis - Role based dashboards

18. 18
Medical Software Engineering Template
Information synthesis - Full traceability

19. 19
Medical Software Engineering Template
Information synthesis – Integrated Product Risk Management

20. 20
Medical Software Engineering Template
Development process management – V-model, Waterfall

21. 21
Medical Software Engineering Template
Product Risk Management - Agile

22. 22
Medical Software Engineering Template
eDocument management – Part11 compliance

23. 23
Medical Audit and CAPA management
Scope

24. VISIT US AT
https://intland.com/retina/medical-device-development/
BOOTH A3!
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