7.3.4 Design and development review

At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements (see 7.3.1)
a) to evaluate the ability of the results of design and development to meet requirements, and
b) to identify any problems and propose necessary actions.

Participants in such reviews shall include representatives of functions concerned with the design and
development stage(s) being reviewed, as well as other specialist personnel (see 5.5.1 and 6.2.1).
Records of the results of the reviews and any necessary actions shall be maintained (see 4.2.4).
bag
quality_public
created
Fri, 20 Mar 2015 00:43:20 GMT
creator
dirkjan
modified
Fri, 20 Mar 2015 00:43:56 GMT
modifier
dirkjan
tags
ISO13485