Simplicity and ease-of-use in Risk Management
Based on the regulatory requirements on Safety Risk Management, the medical device industry invested a considerable amount of time and efforts to generate and maintain risk management documentation. We should now be ready for the next step, to turn these investments into value adding tools and to make them easier-to-use for engineers. This presentation will show how to simplify risk management and how to use the information more effectively while carefully avoiding overloaded and non-sustainable quality systems.
Templates for Safety Risk Management
The attached templates may be used for Risk Management activities. Trainings are available for including workshops.
ISO 14971:2019
As a quality practitioner in medical devices I was heavily looking forward to the 3rd edition of ISO 14971 - Application of risk management to medical devices. In a time of deep regulatory changes (ISO 13485:2016, European MDR and IVDR, MDSAP) there was a threat of another big game changer on the horizon. The recent publication of the ISO 14971:2019 however, shows that the technical committee was probably very aware of the current work load in medical device industries and did, that’s my first opinion, quite a good job. There are not too many changes to the standard and some improvements were made. Accordingly I revised the templates on my webpage to the new version of the standard.
Attached files:
Risk Management File 2019
Combining FMEA and HACCP
Simplicity and ease-of-use in Risk Management
Template Risk management Report 2019
Template Risk Analysis (FTA type)
Template Risk Analysis (HA-FMEA type)
Risk Management Plan 2019
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