The document discusses ISO 14971, highlighting best practices for medical risk management in device development. It covers risk identification, assessment, control measures, and the overall process involved in mitigating hazards. Additionally, the document mentions a live demonstration of requirements management capabilities provided by Intland Software, along with resources for further reading.

1. ISO 14971: Medical Risk
Management Best Practices
Ben Hörömpöly
22 June 2016

2. 2
Agenda
1. Risk management in medical device
development
2. Requirements of medical standards
and regulations
3. ISO 14971: Medical devices –
Application of risk management to
medical devices
4. Live demo of codeBeamer‘s
Requirements Management
capabilities

3. 3
Intland Software
Webinar info
o Live demonstration will be followed by
a Q&A session
o Webinar recording will be available at
www.intland.com/webinars-events/
o Please register to our upcoming
webinars
o Evaluating & Selecting an ALM
Solution

4. 4
Intland Software
About us
o Founded in 1998
o Headquarters in Stuttgart,
Germany
o codeBeamer ALM
o Office in Silicon Valley, CA, USA
o Partners: Lufthansa Industry
Solutions
o Resellers: in UK, China, Korea,
Taiwan, France, Italy

5. 5
Our Clients
Medical
Automotive
Aviation &
Defence
High Tech &
Embedded
Other
2016

6. 6
ISO 14971: Agile Requirements Best Practices
Risk Management
• Identifying
• Understanding
• Controlling
• Preventing
failures that
may result in
hazards
http://vignette1.wikia.nocookie.net/fall
out/images/c/c0/VaultBoyFO3.png/revi
sion/latest/scale-to-width-
down/750?cb=20110809182235

7. 7
ISO 14971: Agile Requirements Best Practices
Risk Management Process
Overall risk management process: Risk control measures:
http://www.wipro.com/documents/resource-center/library/Whitepaper_Medical_Devices_Basic_Principles_of_Risk_Management_for_Medical_Device_Design.pdf
http://www.prestonhire.com.au/site/DefaultSite/filesystem/images/safety/hazard-diagram3.png

8. 8
ISO 14971: Agile Requirements Best Practices
Risk Management Process
Software Process:
• Identify software items
• Identify causes of contribution
hazards
• Define risk control measures
• Verify risk control measures
• Document Traceability
Safety Classes:
• Class A
• Class B
• Class C
Safety Security

9. 9
ISO 14971: Agile Requirements Best Practices
ISO 14971
1. Risk Identification
2. Classification and Assessment
3. Hazard Analysis
4. Risk Reduction Plan
5. Risk Mitigation Actions
6. Documentation and Reporting

10. 10
ISO 14971: Agile Requirements Best Practices
Risk Management in ISO 14971
Risk Management is a Process:
Risk Assessment
Risk Management
http://medicaldeviceacademy.com/wp-content/uploads/risk_managment11.png

11. 11
ISO 14971: Agile Requirements Best Practices
Risk vs. FMEA
Risk:
• Uncertainties that matter
• IEC 62304: Software Lifecycle Process
Failure Modes:
• Potential ways your product coul fail
• ISO 14971: Failure Mode and Effects Analysis http://www.weibull.com/basics/risk_level.png

12. 12
ISO 14971: Agile Requirements Best Practices
Resources
• Basic Principles of Risk Management for Medical Device
Design - Ganeshkumar Palanichamy, 2007
• http://www.qualitymag.com/articles/87058-iso-13485-
medical-devices-and-risk-management
• http://www.praxiom.com/iso-14971.htm
• http://fmdic.org/wp-
content/uploads/2010/12/overview-risk.pdf

13. 13
codeBeamer – Live demo

14. Thank you for your attention!
Any questions?
sales@intland.com