Search the Elsmar Cove!
**Search ALL of Elsmar.com** with DuckDuckGo including content not in the forum - Search results with No ads.

Is there any connection between PFMEA and Acceptance Plan

D

DianaBC

Starting to get Involved
#2
#2
Well, I've just learnt (following the audit performed by our Notified Body) that not only that there is connection (which makes sense, at an intuitively level) but it has to be documented. I'm still thinking how to do it. Any help would be much appreciated!
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
L Connection between IEC 62304 and Chapter 14 of IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
J Connection between Technical File and Declaration of Conformity CE Marking (Conformité Européene) / CB Scheme 2
F Functional connection between ME and non-medical equipment in different rooms IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Connections between PFMEA (Process FMEA) and the Control Plan. FMEA and Control Plans 20
M Connection between DFMEA and PFMEA - What must be transferred to the PFMEA? FMEA and Control Plans 9
Similar threads
Connection between IEC 62304 and Chapter 14 of IEC 60601-1
Connection between Technical File and Declaration of Conformity
Functional connection between ME and non-medical equipment in different rooms
Connections between PFMEA (Process FMEA) and the Control Plan.
Connection between DFMEA and PFMEA - What must be transferred to the PFMEA?
Top Bottom