Risk management in the development of medical devices. This presentation was for a webinar where we discussed the basics of risk management, a general risk management lifecycle, the requirements of certain relevant standards (ISO 14971, IEC 62304, US FDA Title 21 CFR Part 11), and the practical method called HFMEA. The live demonstration shows you how risks can be managed and compliance achieved using the advanced risk management features of codeBeamer ALM, and also demonstrates the use of our (general) FMEA template.

1. Risk Management in
Medical Device Development
Peter Haller & Kristof Horvath
13 May 2015

2. 2
Agenda
1. Medical device safety
2. Risks in medical devices
3. Risk management lifecycle
4. HFMEA
5. Live demonstration

3. 3
Intland Software
Webinar info
• Live demonstration will be followed
by a Q&A session
• Webinar recording will be
• available at
http://intland.com/webinars/
• Sign up for our upcoming webinars

4. 4
o Founded in 1998
o Headquarters in Stuttgart, Germany
o Office in Silicon Valley, USA
o Our ALM solution includes:
• Requirements Management
• Software Development Management
• QA & Test Management
• Demand Management
• IT Operations (DevOps)
Intland Software
Introduction

5. 5
Intland Software
Automotive
High Technology
Defense
Finance
Medical
Other
Our clients

6. 6
• Patient safety a concern
• About 10% of patients harmed by medical errors (WHO)
• Errors in medical devices harm patients and manufacturers alike
(through model recalls)
• High percentage of errors caused by software failures (24% in 2011
according to FDA research)
Risk Management in Medical Device Development
Medical device safety

7. 7
• The later you catch issues, the more expensive it's going to be to
fix them (recalls)
• Risk mgmt could help:
o Shorten time to market
o Increase product quality
o Ensure reliability and safety
• Industry regulations, standards (ISO 14971, IEC 62304, US FDA
Title 21 CFR Part 11)
Risk Management in Medical Device Development
Risks in medical devices

8. 8
1. Risk Identification
2. Classification and Assessment
3. Hazard Analysis
4. Risk Reduction Plan
5. Risk Mitigation Actions
6. Documentation and Reporting
Risk Management in Medical Device Development
Risk management lifecycle

9. 9
• Designed by the VA National Center for Patient Safety (NCPS)
• Combines the detectability and criticality steps of FMEA into a process
represented by a Decision Tree
• Replaces RPN with Hazard Score
Steps:
1. Define topic
2. Assemble team
3. Describe process graphically (flowchart)
4. Hazard analysis
5. Decision tree: Proceed or Stop?
Risk Management in Medical Device Development
Healthcare Failure Mode and Effects Analysis (HFMEA®)

10. 10
Watch our live demo now!

11. Thank you for your attention!
Any questions?
sales@intland.com
We are looking forward to hearing from you!