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Class 1 Devices by Peter J Ogrodnik

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Chapter 6

The Home Run

Abstract

This chapter summarizes the process that is required to meet the requirements to enable the manufacturer to show that their device meets the MDD and FDA requirements to be called a medical device, and therefore, be able to be sold as such.

Keywords

technical file
DHF
regulatory
MDD
PMS

6.1. A summary of activity

I would hope that you will have recognised that my efforts have been targeted at you meeting the design control requirements of both the Food and Drug Administration (FDA) and the Medical Devices Directive (MDD). If you have followed the holistic approach, whereby sub-contractors have been included in the design process, then you are well on the way to meet the Good Manufacturing Practice (GMP) ...

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