Determine basic product characteristics

General :
Version:	1.0

Project :
Author:	Wolfgang Kern
Created:	03.08.2014 22:46:48
Modified:	17.09.2015 11:57:46

Diagram Elements :

Device classifications

Determine applied parts

FDA - device classification

Product Manager

RA Specialist

State product life cycle / expected service life

Project Manager

Basic product characteristics determined

Taylor development life cycle according to MD classification

Quality and risk management plan

Product Requirement Specifications (PRS)

FDA medical device classification

CE medical device classification

Do medical device classification

Determine intended use

Need for basic product characteristics