CFR 820.30 Design controls

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You are here: Home Compliance Master Compliance CFR 820 Code of Federal Regulations Title 21 Subpart C - Design Controls CFR 820.30 Design controls CFR 820.30 Design controls

General :
Version:	1.0

Project :
Author:	Wolfgang Kern
Created:	31.03.2014 09:41:25
Modified:	20.08.2014 22:41:23

Diagram Elements :

Do SW validation

Manage DHF

Manage and create PCRs

Manage engineering change requests (ECRs)

Do design transfer

Do device hazard analysis

Do product validation

Do system / usability verification

Do module verification

Review product release

Review design transfer

Review validation phase

Review verification phase

Create DRS

Review design phase

Create SysRS / US

Create USI

Create PRS

Review requirement phase

Quality and risk management plan

Create / update quality and risk management plan

Manage development process

Subpart C - Design Controls : Subpart C - Design Controls

CFR 820.30 j) Design history file

CFR 820.30 i) Design changes

CFR 820.30 h) Design transfer

CFR 820.30 g) Design validation

CFR 820.30 f) Design verification

CFR 820.30 e) Design review

CFR 820.30 d) Design output

CFR 820.30 c) Design input

CFR 820.30 b) Design and development planning

CFR 820.30 a) Establish and maintain design control procedures

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