Experiential Learning Program of the CDRH

Recommendation

7/8 May 2024

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How to foster Continual Quality Improvement

Under the heading "CDRH's Experiential Learning Program", the FDA offers an interesting advanced training program. It is aimed at FDA employees who are "reviewers", i.e. who evaluate medical devices as part of the "approval procedure". The idea behind the program is to address experienced FDA staff as well as newcomers so that they can get to know and deepen their practical experience in the manufacture of medical devices. This means that the FDA staff will visit companies that manufacture medical devices upon appointment. The visit is not about inspection or other regulatory measures. The aim is simply to improve the "reviewer's" knowledge, also with regard to new technologies.

You can find details about the CDRH's Experiential Learning Program on the FDA website.