MICHAEL SCHAEFER

Quality Management
Regulatory Affairs
in Medical Devices

 

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.

2013-01-06 16:05:16

Templates for Safety Risk Management

The attached templates may be used for Risk Management activities. Trainings are available for including workshops.

2013-01-29 18:06:18

Harms and severities - applying IMDRF and CTCAE

Manufacturers sometimes struggle to determine adequate medical terms and to assign reasonable severity ratings as required by ISO 14971. In the past there was very limited guidance available discussing this task. In the meanwhile there were some helpful documents published making the challenge a bit easier and much more transparent. I want to remind you of IMDRF guidance on terminologies for adverse events and CTCAE Common Terminology Criteria for Adverse Events. Both fit together really well, see my article attached.

2020-05-23 16:12:36

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.

2019-12-17 08:17:08

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