A compliant, effective and pragmatic implementation of ISO 14971 is a challenge for many medical device suppliers:

• What are the applicable hazard and hazardous situations?
• What are the probabilities of harm (risk profile) of my device?
• How do I determine the risk acceptability criteria for my product.
• To which detail I have to document and maintain risk management records?
• How to summarize your risk management approach to the FDA or DECRA?
• Hoe do I align the opinions w.r.t. risk management within the organisation?
• How do I organize post market surveillance?
• …….

I have developed a framework and way of working for the implementation of ISO 14971. This framework is recognized by the Quality and Regulatory consultants of Philips Healthcare, DECRA and CSA as a best practice. Elements of my approach are:

• Take an “outside-in” view instead of an “inside-out” view.
• Use Bow Tie diagrams to summarize and communicate.
• Use pre-defined harzard and hazardous situations list in the risk management process description and templates.
• Correlate pre-market and post-market risk management data by labeling of the post-market data.

I will not only explain to you “What you should do” but more importantly I will help you with “How you can do it” in a pragmatic and efficient way.