Informational EU – Some documents related to Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices

Thread starter Similar threads Forum Replies Date
M Informational EU – Manufacturer incident report (MIR) for serious incident- template 2020 (Directives and new regulations) version 7.2 and related documents Medical Device and FDA Regulations and Standards News 2
x-files Procedure writing - Section - Related documents Document Control Systems, Procedures, Forms and Templates 8
drgnrider Definition of "Manage" as used in ISO 14001 related Documents ISO 14001:2015 Specific Discussions 3
A FDA's Medical Device Inspection related Documents 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
R Which documents to control apart from QMS related procedures? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
A Document Relationship Matrix - Keeping Track of References to Related Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
P AS 9100 Clause 7.1 thru 7.2.2 - Examples of related documents AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
L Customer Requirements related to Retention Documents and Records period Records and Data - Quality, Legal and Other Evidence 1
B Looking for GMP and HACCP related documents Various Other Specifications, Standards, and related Requirements 1
I Confidentiality Audit - Confidential Infomation and related Documents Audit General Auditing Discussions 9
Sidney Vianna AS 9100 Related Documents AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
Sidney Vianna AS9100 related documents AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
K Different "levels" of quality planning and the related documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
eule del ayre Documented Information - Periodic Review of Documents? IATF 16949:2016 / ISO 9001:2015 IATF 16949 - Automotive Quality Systems Standard 34
M Retention period of documents and records ISO 13485:2016 - Medical Device Quality Management Systems 1
D Offsite storage of QMS documents ISO 13485:2016 - Medical Device Quality Management Systems 9
K Joint approval between OEM and Manufacturer on Design Documents ISO 13485:2016 - Medical Device Quality Management Systems 4
was named killer AS 9100D - Calibration Instructions - Controlled documents? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
N Audit non-compliance API Q1 - Use of External Documents 4.4.4 in Product Realization Oil and Gas Industry Standards and Regulations 5
C Corrective action for failure in documents control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
A QMS Overhaul - Reorganizing and Renaming Documents - Internal References Document Control Systems, Procedures, Forms and Templates 18
J Controlled information versus defined documents / records ISO 13485:2016 - Medical Device Quality Management Systems 3
D DQ documents of new equipment - Function specification Qualification and Validation (including 21 CFR Part 11) 0
B Using Unreleased Documents & Process Maps for Internal Audit purposes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
N Device Labeling - Medtronic Ventilator Files (Risk Management documents) Coffee Break and Water Cooler Discussions 2
qualprod To set frequency to review documents in ISO 9001 7.5? Document Control Systems, Procedures, Forms and Templates 13
S Mandatory documents vs shall "something" but without mandatory documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
I Reissuing documents due to missing version / issue numbers Document Control Systems, Procedures, Forms and Templates 3
I Dating controlled documents after changes - Revision History Document Control Systems, Procedures, Forms and Templates 13
C Document Control Stamps - Does anyone still stamp their documents? Document Control Systems, Procedures, Forms and Templates 24
M Advertising medical devices in the U.S - Advertising regulations or guidance documents Other US Medical Device Regulations 3
R Process control documents - Context of API Spec Q1, Clause 5.7.1.3 Other ISO and International Standards and European Regulations 0
C Identifying and Controlling External Documents Document Control Systems, Procedures, Forms and Templates 3
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
M EU MDR - Annex II 3b - What documents fall under this requirement? EU Medical Device Regulations 3
H New 510K VS Documents about design change. Other US Medical Device Regulations 1
R Implementing Design History Documents/ Technical Documents in the QMS ISO 13485:2016 - Medical Device Quality Management Systems 3
R Approvals on QMS Documents - ISO 13485 Requirements Document Control Systems, Procedures, Forms and Templates 2
K Mandatory Documents for EU authorized Representative under MDR CE Marking (Conformité Européene) / CB Scheme 8
Sidney Vianna Interesting Discussion Hello IAF. Are you listening? Please explain the inconsistency in your IAF Mandatory Documents (2019) ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 6
I QMS documents required at each stage of Software development IEC 62304 - Medical Device Software Life Cycle Processes 5
qualprod Controlling documents in two different Applications ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
R Do we need to treat local law as external origin documents? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
I Sales Documents in scope for ISO-9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
shimonv Informational New guidance documents about EUDAMED - April 2019 EU Medical Device Regulations 1
M Which documents must be updated upon product validation? Document Control Systems, Procedures, Forms and Templates 1
L Digitalization of documents - FDA and ISO 13485 Other Medical Device Related Standards 1
G Correction fluid found on documents that are reviewed Qualification and Validation (including 21 CFR Part 11) 11
M Informational IMDRF – Proposed update to Clinical Evaluation documents Medical Device and FDA Regulations and Standards News 0
I R&D prototype documents need to be controlled? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5

Similar threads

Top Bottom