Design History File

General :
Version:	0.9

Project :
Author:	Wolfgang Kern
Created:	27.02.2014 18:24:43
Modified:	27.03.2017 12:11:30

Diagram Elements :

Device classifications

Glossary

Morphological box

Design concept

Product (clinical) validation plan

Product (in-house) validation report

Design-FMEA (DFMEA)

System Requirement / Use Specifications (SysRS/US)

Product Requirement Specifications (PRS)

Project plan

Product (clinical) validation report

Usability Specification Inputs (USI)

Test report

Release for product development

Product (in-house) validation plan

Release for production

Integration plan

Quality and risk management plan