Medical Devices Compliance and Regulations Overview

M

Mimosa777

#1
Hi there,

im looking for a powerpoint presentation to have an idea on how to present a basic training course on medical devices compliance and regulations on high level overview. Can you polease refer to some useful link or presentation that already exist..

Thnak you in advance.
 
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K

KenBlock

#5
Re: Medical Devices - Regulatory overview

Here are two overviews developed by FDA:
- high level medical device regulatory overview (company registration, quality system, applications, small business qualification, etc.), and
- Quality System Regulation overview developed by Kim Trautman, the FDA expert in that area.
 

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