RD_Research and Development

General :
Version:	0.9

Project :
Author:	Wolfgang Kern
Created:	21.02.2014 17:48:27
Modified:	16.09.2019 16:59:48

Diagram Elements :

Develop System

Determine basic product characteristics

Select and qualify development tools

Do design concepts

Develop Software

Do / update clinical evaluation

Do device hazard analysis

Register MD in EU

Select and qualify development partner

Provide SERVICE LEVEL 3

Do CE product approval

Create USI

Create PRS

Manage development process

Review product release

Do product training

Review design transfer

Review requirement phase

Manage engineering change requests (ECRs)

Create DMRs and MMRs

Start development project