SBS - The best value in QMS software

Notice the extended scope of this forum? Web sites added.

QMS for Medical Device Companies
Elsmar Forum Sponsor
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
R Do we need issue ECN (Engineering Change Notice) towards updated Material Specification? Design and Development of Products and Processes 2
A Document Change Notice vs complete System re-write Manufacturing and Related Processes 4
L Significant change notice for outsourced warehouse Medical Device and FDA Regulations and Standards News 2
S Is the document author required to be identified as part of Document Change Notice? ISO 13485:2016 - Medical Device Quality Management Systems 5
L Getting Notice of Revision and Accessing Public Draft Copies of ISO Standards Service Industry Specific Topics 2
M Informational Health Canada – Notice: Revisions to the Guidance Document: Management of Applications for Medical Device Licences Medical Device and FDA Regulations and Standards News 0
W Informational MDSAP Substantial change / Change of notice forms Document Control Systems, Procedures, Forms and Templates 2
shimonv Non-significant notice of change to notified body EU Medical Device Regulations 4
M Medical Device News Olympus Medical pleads guilty to failing to file events notice: Justice Department Medical Device and FDA Regulations and Standards News 0
M Medical Device News Health Canada Notice of intent: Strengthening the post-market surveillance and risk management Canada Medical Device Regulations 1
S Change notice while switching to injection molding technique for manufacturing EU Medical Device Regulations 1
M MDSAP Transition - Health Canada Website Notice on Apr 13 2018 Canada Medical Device Regulations 1
S Difference between an Advisory Notice (ISO 13485) and a Field Safety Notice? ISO 13485:2016 - Medical Device Quality Management Systems 3
R ISO 13485 - Advisory Notice Requirements ISO 13485:2016 - Medical Device Quality Management Systems 5
J Employer Warning Notice a Controlled Document? Document Control Systems, Procedures, Forms and Templates 7
S Definition Legal Hold Notice - What is a Legal Hold Notice? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
R Two Week Notice Backlash Coffee Break and Water Cooler Discussions 17
somashekar Medical Device Establishment Registration and Listing - Notice of Changes for FY 2013 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Q Should advance notice be given for Disaster Recovery Audit? Business Continuity & Resiliency Planning (BCRP) 9
T CFDA issues notice for Small Oxygen Respirators (9/16/2013) China Medical Device Regulations 0
D Relabeling due to FDA Detention Notice Manufacturing and Related Processes 6
J Training/Notice when a New Document is Released or a Document is Changed Training - Internal, External, Online and Distance Learning 13
AnaMariaVR2 Medical Device Establishment Registration and Listing - Notice of Changes for FY 2013 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
B End of Contract Notice to Employer Career and Occupation Discussions 11
T What should I put on my Quality Notice Board? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
T What should I put on my Environmental Notice Board? Miscellaneous Environmental Standards and EMS Related Discussions 4
B Issue of Certificate requiring Supplemental Notice General Measurement Device and Calibration Topics 5
A Is a Change Notice needed if I change the Procedures and Work Instructions?? Document Control Systems, Procedures, Forms and Templates 4
D Recall, Safety Notice or Training? - Medical Device with two identical complaints 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
L Transmittal Form/Notice not being signed and returned by Clients ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S Management Notice of Change - Sample Wanted AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
K Records Disposal Notice Form Records and Data - Quality, Legal and Other Evidence 6
M Is ECN (Engineering Change Notice) Necessary for Part Number Change IATF 16949 - Automotive Quality Systems Standard 4
L Lateness Delivery Notice to Customer ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
somashekar FDA cGMP on Feedback, Advisory Notice and Customer Property 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
L FDA Audit - How much advance notice do foreign manufacturers get? ISO 13485:2016 - Medical Device Quality Management Systems 4
Sidney Vianna Short notice audits - Have you been through or triggered one? Registrars and Notified Bodies 4
J Document Change Notice Content Document Control Systems, Procedures, Forms and Templates 24
Q Notice to Customer for Discontinued Product IATF 16949 - Automotive Quality Systems Standard 7
A Job Relieving Period? (Giving Notice) - Help Career and Occupation Discussions 11
K PCN Notice (Product or Process Change Notice) Content Requirements per JESD46C Various Other Specifications, Standards, and related Requirements 4
A Customer Return or Advisory Notice? ISO 13485:2016 - Medical Device Quality Management Systems 6
R AS9016 - Notice of Change template in either Word or Excel AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
J Engineering/Document Change Notice Procedure required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
P How to specify criteria for TECN (Temporary Engineering Change Notice) Document Control Systems, Procedures, Forms and Templates 3
E Medical Device Advisory Notice Procedure ISO 13485:2016 - Medical Device Quality Management Systems 4
J Prior Notice of Sub-Supplier or Material Source Change - PPAP Requirements Question APQP and PPAP 13
K Recall or advisory notice sufficient for software ISO 13485:2016 - Medical Device Quality Management Systems 9
M Technical Notice vs. Service Bulletin - Definition and differences Federal Aviation Administration (FAA) Standards and Requirements 6
P Document Change Notice (DCN) vs. Document Release Notice (DRN) - Differences Document Control Systems, Procedures, Forms and Templates 7

Similar threads

Top Bottom