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Qestion is on the EU MDD requirements and audit non-conformance.
For CE Mark Assessment on a medical device client received a non-conformance
because standards referenced in product spec and technical file docs were
not checked for updates to standards referenced and files were not assessed for update impacts.
Non-conformance was "Assessment of new/revised standards impact on
existing devices needs to be part of Company's process. The review should
be documented and action plans developed."
Applicable Standard Cited: Continued Compliance to MDD Annex 1: Ref Annex I, II
First, does observation make sense to you.
2nd, Does anyone have a checklist, process or flowchart that depicts or guides
the needed review?
Alternately How do you (posting respondents) assure most current standard revision like electronics (IEC 60601-?-? ) called out is updated in technical file and file checked for impacts?
Thanks BILLH007
For CE Mark Assessment on a medical device client received a non-conformance
because standards referenced in product spec and technical file docs were
not checked for updates to standards referenced and files were not assessed for update impacts.
Non-conformance was "Assessment of new/revised standards impact on
existing devices needs to be part of Company's process. The review should
be documented and action plans developed."
Applicable Standard Cited: Continued Compliance to MDD Annex 1: Ref Annex I, II
First, does observation make sense to you.
2nd, Does anyone have a checklist, process or flowchart that depicts or guides
the needed review?
Alternately How do you (posting respondents) assure most current standard revision like electronics (IEC 60601-?-? ) called out is updated in technical file and file checked for impacts?
Thanks BILLH007