Informational EU – Meeting minutes – Competent Authorities on Substances of Human Origin Expert Group

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M Informational EU – Minutes of the 24 July 2019 SCHEER Working Group on safety of breast implants in relation to anaplastic large cell lymphoma (BIA-ALCL) meeting Medical Device and FDA Regulations and Standards News 0
M Informational EU – SCHEER – Minutes of the Working Group meeting on guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devic Medical Device and FDA Regulations and Standards News 1
D Documenting Meetings through Meeting Minutes or a Form ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D Management Review Meeting Agenda and Minutes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
D Integrated 9001, 14001, 18001 Management Review Meeting and Minutes Management Review Meetings and related Processes 10
I Content to be included or excluded in Design Control Meeting Minutes ISO 13485:2016 - Medical Device Quality Management Systems 4
C Example of Management Review Meeting Minutes - ISO 17025 ISO 17025 related Discussions 9
G Minutes (Records) from a Management Review Meeting Quality Management System (QMS) Manuals 4
O Should Staff be allowed to see Management Review Meeting Minutes? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
M Document Control in charge of taking Meeting Minutes? Document Control Systems, Procedures, Forms and Templates 23
Z Supplier Meeting Minutes Template needed Document Control Systems, Procedures, Forms and Templates 1
G Is there a requirement for Management Review Meeting Minutes? Management Review Meetings and related Processes 39
Gert Sorensen Requirement for specified agendas and meeting minutes when documenting projects? Document Control Systems, Procedures, Forms and Templates 2
R Altering the Actual Date of the Management Review Meeting Minutes Management Review Meetings and related Processes 69
M Management Review - Minutes of Meeting Management Review Meetings and related Processes 9
V Quality review Meeting with Customer for complaints we received Customer Complaints 6
S Has anybody done IMS - Management Review Meeting ISO 14001:2015 Specific Discussions 8
C Does a CE mark infer meeting all applicable standards? CE Marking (Conformité Européene) / CB Scheme 4
T Management review meeting workflow ISO 13485:2016 - Medical Device Quality Management Systems 9
J Any diverging opinions regarding audit findings or conclusions must be resolved no later than the closing meeting ISO 13485:2016 - Medical Device Quality Management Systems 13
M Informational EU – 12th Meeting of the Working Group on Guidelines on benefit – risk assessment of Phthalates in Medical Devices Medical Device and FDA Regulations and Standards News 0
M Informational Next meeting of the Medical Device Coordination Group (MDR/IVDR) – 20 June 2019 Medical Device and FDA Regulations and Standards News 2
M Informational 2019 Meeting Materials of the General and Plastic Surgery Devices Panel Medical Device and FDA Regulations and Standards News 0
R Major nonformance finding was given during a closing meeting of a ISO9001 certification audit General Auditing Discussions 76
M Informational RIVM – Summary International Expert Meeting on breast implant-associated lymphoma Medical Device and FDA Regulations and Standards News 0
M Informational The USFDA Announces General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting on March 25-26, 2019 Medical Device and FDA Regulations and Standards News 0
M Medical Device News USFSA – 2019 Meeting Materials of the Obstetrics and Gynecology Devices Panel Medical Device and FDA Regulations and Standards News 0
M Informational ISO TC 210 IEC SC 62A JWG 1 Medical device risk management – São Paulo meeting 2019 Medical Device and FDA Regulations and Standards News 6
M Medical Device News ISO TC 210 IEC SC 62A JWG 1 Medical device risk management – São Paulo meeting 2019 Medical Device and FDA Regulations and Standards News 0
D FDA Pre-Submission Meeting Advice US Food and Drug Administration (FDA) 0
M Informational ISO TC 210 JWG 1 meeting in São Paulo – Revision of ISO 14971 and ISO TR 24971 – Medical Device Risk Management Medical Device and FDA Regulations and Standards News 0
M FDA News FDA announces panel meeting on surgical mesh placed transvaginally to treat pelvic organ prolapse Medical Device and FDA Regulations and Standards News 0
L 510 (K) Pre-Sub meeting - Does it worth? US Food and Drug Administration (FDA) 4
qualprod ISO planning annual meeting? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
T FDA Q-Submission Informational Meeting 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
Marc IAQG Cleveland, Ohio Meeting - October 16-19, 2017 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
K Meeting the requirements of ISO 13485:2016 Cl. 4.1.4 within a wiki-based QMS ISO 13485:2016 - Medical Device Quality Management Systems 3
B IATF 16949 Cl. 4.3.2 - Meeting Customer Specific Requirements IATF 16949 - Automotive Quality Systems Standard 13
Z MRM (Management Review Meeting) Template for ISO 9001:2015 Management Review Meetings and related Processes 3
S Corporate Quality Manager keeping me out of the Management Review Meeting Management Review Meetings and related Processes 28
F Development Meeting with the FDA - Approval Pathway for a Combination Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M ISO 14971:2007 Revision Approved - The Delft ISO TC 210 plenary meeting - Nov 2016 ISO 14971 - Medical Device Risk Management 2
L Auditing Top Management - Meeting Competency Requirements and Questions to Ask General Auditing Discussions 11
J Organizational Knowledge Requirements - Meeting ISO 9001:2015 Clause 7.1.6 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 60
D What should be included in Management Review Meeting for ISO 9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
Q REACH due dilligence and meeting the ever moving SVHC target RoHS, REACH, ELV, IMDS and Restricted Substances 5
N Incompleted tasks from previous management review meeting Management Review Meetings and related Processes 1
B Meeting the requirements of ISO/TS16949 Clause 6.2.2.3 IATF 16949 - Automotive Quality Systems Standard 4
L CB finding on Management Review Meeting Management Review Meetings and related Processes 32
I Meeting AS9100, FAA, Transport Canada, EASA Training Requirements - Vent/Rant Coffee Break and Water Cooler Discussions 2

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