Aligning QMS and Engineering Processes in Medical Product ...€¦ · 23/10/2019 Aligning QMS and Engineering Processes in Medical Product Development Szabolcs Agai, Functional Safety

23/10/2019

Aligning QMS and Engineering Processes

in Medical Product Development

Szabolcs Agai, Functional Safety ExpertIntland Professional Services

2

Agenda • 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

• 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 areIntland Software & Medical Device Developers

4

QMS meets ALM

Engineering team QA team

5

Current Practices and Challenges

• Isolated data islands• Fragmented, randomly redundant data• Low data integrity

• High effort to get management information• High cost of ownership• High exposure to human error• Lack of real traceability

Task Management

Document sharing

Requirements Management

QMS

Documents in

Wiki

MS Word

6

Medical Software Engineering TemplateChallenges & Compliance

7

Intland RetinaALM + eQMS is the solution

0

Medical QMS Process framework

Good engineering practices

8

Our Medical Templates support the development of:

US FDA: Software as a Medical Device (SaMD)

EU: Medical Device Software (MDSW)

9

Intland RetinaValues

Analyze patient safety concerns

Intland Retina is a software platform that enables medical software development organizations to:

Save time and ensure quality to deliver safe and best in class

medtech software

Minimize the burden of dealing with administrative tasks

Deliver consistent design and development content for regulatory purposes

10

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

11

Intland RetinaProcess approach

Pre-built process templates

• Medical Software Engineering• Medical Audit and CAPA

management

Custom tailoring • Additional and Custom Use Cases

12

Medical Software Engineering TemplateKey supported processes

13

Medical Software Engineering TemplateTemplate approach

• 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

14

Medical Software Engineering TemplateTemplate approach – Logical Data Model

15

Medical Software Engineering TemplateTemplate approach – Information synthesis

DataData

DataData

DataData

DataData

Data

Data

Data

Data

Data

Information

16

Medical Software Engineering TemplateTemplate approach – Information synthesis (Role-based dashboards)

17

Medical Software Engineering TemplateTemplate approach – Information synthesis (Full lifecycle-wide traceability)

18

Medical Software Engineering TemplateProduct Risk Management – Gapless traceability

19

Medical Software Engineering TemplateDevelopment process management – V-model, Waterfall

20

Medical Software Engineering TemplateProduct Risk Management - Agile

21

Medical Software Engineering TemplateeDocument management – Part11 compliance

22

Medical Audit and CAPA managementScope

VISIT US AT

https://intland.com/retina/medical-device-development/

BOOTH A3!

OR LEARN MORE AT