Part selection for R&R studies

Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
Ron Rompen CMM Probe Size Selection when doing a CMM Layout of a Part Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
B Combat Low Part to Part Variation in GRR Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 8
C Quality Manager as part of Management - 13485 ISO 13485:2016 - Medical Device Quality Management Systems 9
A Complaint review as part of the complaint handling process? ISO 13485:2016 - Medical Device Quality Management Systems 3
D FDA Guidance on Computer Software Assurance versus 21 CFR Part 11 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
F Physical Part Measurement General Measurement Device and Calibration Topics 6
S Clean room not part of my certification ISO 13485:2016 - Medical Device Quality Management Systems 3
A MDR ANNEX XI part A or Part B EU Medical Device Regulations 0
J Part submission warrant for Level 1 PPAP APQP and PPAP 1
K How to handle GTINs for different configurations of one device with one part number? Other Medical Device Related Standards 0
A 60601-1 : Integrated Dry ECG Electrodes = 2 Patient connections inside 1 applied part? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
E Zero part to part variation - Gage R&R project Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 15
0 To which part of 13485 does this refer? ISO 13485:2016 - Medical Device Quality Management Systems 3
D Separation of F-type applied part and remaining parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
S ISO 9001:2015 vs 21 CFR Part 211 matrix Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
D CFR Title 14: Aeronautics and Space PART 120—DRUG AND ALCOHOL TESTING PROGRAM Federal Aviation Administration (FAA) Standards and Requirements 3
D Is PMCF really a continuous activity per Annex XIV,Part B? EU Medical Device Regulations 5
M 21 CFR 820 vs 21CFR820 vs 21 CFR Part 820 Document Control Systems, Procedures, Forms and Templates 3
N BF-type applied part MOPP vs secondary IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
D Relabelling a component that will be sold as a spare part - Do I become legal manufacturer? EU Medical Device Regulations 2
T Single Fault Condition IEC 60601 Clause 8.7.1 shorting Cr/Cl in Patient Applied Part IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
D Partial FAI - AS9102 - One single drawing has 10 part numbers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Anonymous16-2 21 CFR Part 11 - Steps to take if we want to validate an electronic system Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
T ISO 13485 8.3 - Non-Conforming Materials - on-line rework or part of process? ISO 13485:2016 - Medical Device Quality Management Systems 11
DuncanGibbons Should the requirements FAA/EASA Part 21 be addressed within the QMS and AS9100D quality manual? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
K IEC 62304 compliance - Code reviews as part of verification strategy IEC 62304 - Medical Device Software Life Cycle Processes 5
G Gage R&R - Where am I going wrong? Part of a FAIR submission (Aerospace) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
A 21 CFR part 11 - section 11.100 - Electronic Signature Certification Other US Medical Device Regulations 6
M AS9102B Detail Part/Assembly FAI Form 1 box 13; AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M 2xMOPP insulation for Applied Part B. IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
A ISO 41001:2018 - Clause No.8 Operations Part Quality Management System (QMS) Manuals 2
NDesouza Getting Rid of Part Marking Errors Benchmarking 40
L Wearables 21 CFR Part 11 compliance Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
DuncanGibbons How are part cut out specimens made and tested? Manufacturing and Related Processes 1
S Internal calibrations - Part of an ISO 17025 accredited testing laboratory (Automotive) ISO 17025 related Discussions 16
Ed Panek 21 CFR Part 820 - FDA Label Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
S CQI-23 - Molding System Assessment - Control of part weight IATF 16949 - Automotive Quality Systems Standard 5
DuncanGibbons Looking for example aerospace part CAD files to be used for a case study Career and Occupation Discussions 2
T Overvoltages consideration in Applied Part for RMS Calculation. IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
M Informational How to perform a clinical evaluation of medical devices – Part 2 – Level of clinical evidence and what sufficient clinical evidence means Medical Device and FDA Regulations and Standards News 9
E Part 11 Compliance, Excel living documents (i.e. document master list, equipment list, approved supplier list) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
S FAIR - If we have not produced a part in over 2 years, but nothing has changed AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
P Scope of application for IEC 60601-1-11 Medical electrical equipment — Part 1-11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Informational Creating a post market surveillance (PMS) system for medical devices – Part 1 Medical Device and FDA Regulations and Standards News 7
Ed Panek Part 11 Self Certify Memo - What else should it cover? Qualification and Validation (including 21 CFR Part 11) 5
M Informational How to perform a clinical evaluation of medical devices – Part 1 – Overview and sample of activities Medical Device and FDA Regulations and Standards News 0
rezayatmand IEC 60601-2-18 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipmen IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R Question on determining defective units - I am not recording fixture to part rejected Statistical Analysis Tools, Techniques and SPC 5
C Serialised Defective Part Replacement EU Medical Device Regulations 4
B F-type applied part - Separation from ALL(?) other parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 8

Similar threads

Top Bottom