Is there any connection between PFMEA and Acceptance Plan

Highly Rated Gage Tracking - Learn More
Elsmar Forum Sponsor
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
M Connection between DFMEA and PFMEA - What must be transferred to the PFMEA? FMEA and Control Plans 9
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
optomist1 Contour vs. Profile - Is there a connection between "Contour" & "Profile"? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 12
S What is the connection between Ford's phased PPAP and edition 4 from AIAG APQP and PPAP 4
J Patient connection and accessible parts - enclosure IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
C Isolation requirement for USB connection IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Camera / microphone with wifi connection on a medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
M Saline Infusion- Applied Part, Patient Connection IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
V Taper Shaft and Hub Connection Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
S Medical watch Class II (AP Type CF) with USB connection IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
D Defibrillation protection for patient connection except for electrodes IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
B USB-Connection - Creepages and Clearances IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
U PATIENT CONNECTION for HAND-HELD Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
B Detachable Power Supply Cable Connection ESD Clarification IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
R Connection to a generic separate power supply IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
Q ME System - Is a Wireless Connection a "Functional Connection"? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
R Appliance Connection for IEC 60601-1-11 Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
R Is protective earth connection regarded as a part of the applied part? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
Wes Bucey Slow Internet Connection After Work and Weekend Discussion Topics 3
P Test Voltages for a Pulse Transformer used to Isolate the Patient Connection IEC 60601 - Medical Electrical Equipment Safety Standards Series 11
I Connection of Secondary Circuits to Medical Weight Scale Enclosure IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
W Patient Circuits / Patient Connection / Applied Parts - Medical Device Definitions IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
Jim Wynne Tech Guy Radio: Woman Wants Help in Getting Her Stolen Internet Connection Back After Work and Weekend Discussion Topics 2
Colin Cost of Internet connection in hotels Travel - Hotels, Motels, Planes and Trains 55
L Is there any connection betweeen ISO 14001 and RoHS? RoHS, REACH, ELV, IMDS and Restricted Substances 6
T PPAP Appendix F.3 "Customer Plant Connection" - Bulk Materials - Steel Coil Supplier APQP and PPAP 4
O 61010-1 Annex D Protection between HAZARDOUS LIVE circuits and ACCESSIBLE external TERMINALS Other Medical Device Regulations World-Wide 0
W Cross reference between APQP and VDA MLA? APQP and PPAP 0
T Relation between ISMS and QMS for a SaMD Medical Information Technology, Medical Software and Health Informatics 3
K What are the differences between the certificates required for home and medical medical equipment? US Food and Drug Administration (FDA) 1
L Assignment on the link between Quality Gurus & ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
X Difference between the Figure J.6 and J.7 insulation examples IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
W Difference between Appliances and Parts according EASA EASA and JAA Aviation Standards and Requirements 0
X Insulation between opposite terminals of battery IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
M FMEA Severity Scores Between Two Sister divisions? FMEA and Control Plans 6
S Disparity between Job Descriptions in QMS & Contract ISO 13485:2016 - Medical Device Quality Management Systems 7
A Difference between general PMCF and PMS EU Medical Device Regulations 3
F Difference between "misuse" and "off-label use" EU Medical Device Regulations 12
placebo_master What is the difference between "Fitness for Purpose" and "Calibration/Verification"? General Measurement Device and Calibration Topics 6
S Link Between Essential Performance Requirements and Essential Design Outputs 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
G Similarities between format of technical file for CE and ASEAN common submission dossier template (CSDT) CE Marking (Conformité Européene) / CB Scheme 2
B For professionals from an amateur: What are the differences between some plans and procedures? EU Medical Device Regulations 5
Y Relationship Between Appendices to Annex XVII and Annex XVII of REACH regulation REACH and RoHS Conversations 0
T ISO 27001 - 4.3 c - Interfaces and dependencies between activities - how to consider these? IEC 27001 - Information Security Management Systems (ISMS) 2
C Need to understand difference between an actual Calibration vs. a Calibration check General Measurement Device and Calibration Topics 3
H API monogram 4F, The difference between PSL-1 & PSL-2 Oil and Gas Industry Standards and Regulations 5
M Procedure for communication between authorized rep and distributor Other ISO and International Standards and European Regulations 0
J Impact Testing--Is conversion between Izod and Sharpy Possible? General Measurement Device and Calibration Topics 3

Similar threads

Top Bottom