Module 14 2022

22/03/2022

Masterclass: Lecture 1

Principles of the design and development of medical devices

Helen Erwood, Director RA, ESPL

The Organisation for Professionals in Regulatory Affairs

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AN OVERVIEW OF: ● GOOD DESIGN PRACTICE in DESIGN and DEVELOPMENT processes – Identifying a NEED – PLANNING the design process – EXPEDITING the process – experimental DESIGN – Design CONTROLS PRINCIPLES OF THE DESIGN AND DEVELOPMENT OF MEDICAL DEVICES

Masterclass: Lecture 1

The Organisation for Professionals in Regulatory Affairs

2

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