7.3.2 Design and development inputs

General :
Version:	1.0

Project :
Author:	Wolfgang Kern
Created:	06.03.2014
Modified:	10.09.2017 12:14:03

Diagram Elements :

Do / update clinical evaluation

Prepare and apply for clinical study

Review requirement phase

Consider experiences derived from previous developments

Do device hazard analysis

Check and declare compliance with ER 98/37/EEC (if applicable)

Check and declare compliance with ER 93/42/EEC

Create SysRS / US

Create USI

Create PRS

Determine applicable standards

7.3 Design and development : 7.3 Design and development

7.3.2 Inputs shall be reviewed regarding adequacy, completeness, unambigiuity and non conflicting

7.3.2 e) output(s) of risk management

7.3.2 d) other requirements essential for design and development

7.3.2 c) information derived from previous similar designs

7.3.2 b) applicable statutory and regulatory requirements,

7.3.2 a) functional, performance and safety requirements