Create PRS

General :
Version:	1.0

Project :
Author:	Wolfgang Kern
Created:	21.03.2014 10:15:14
Modified:	16.09.2019 14:53:14

Diagram Elements :

Medical device summary report

Product research report

Product (clinical) validation plan

Create validation plan

Create traceability between validation and PRS

Translate customer needs into product requirements

Manager CAM

Model House of Quality if applicable

CAPA Corrective and preventive action

Complaint report

Nonconformity of components

Consider experiences derived from previous developments

Consider customer input

House of Quality

Market research report

Product Manager

RM Representative

PRS specified

Do device hazard analysis

Product Requirement Specifications (PRS)

Create PRS

Pre-Assess (unmet) customer user needs and market information

Intended product development