Module 14 2022

22/03/2022

PRINCIPLES OF THE DESIGN AND DEVELOPMENT OF MEDICAL DEVICES

AN OVERVIEW OF: ● The REGULATORY FRAMEWORK – ISO standards – Notified body expectations – Guidances: EU / UK, FDA, IMDRF

● DOCUMENTING data and decisions

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

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PRINCIPLES OF THE DESIGN AND DEVELOPMENT OF MEDICAL DEVICES

NOTE: ● MUCH OF WHAT WE WILL LOOK AT IN THIS LECTURE WILL BE EXPANDED IN FURTHER DETAIL IN SPECIFIC SUBJECT LECTURES THROUGHOUT THE COURSE

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

4

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