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Informational BSI – MDR Documentation Submissions Best Practices Guidelines

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M Informational Scope of BSI for the MDR – Regulation (EU) 2017/745 on medical devices Medical Device and FDA Regulations and Standards News 0
M Informational First NB designated to the EU MDR regulation – BSI UK Medical Device and FDA Regulations and Standards News 2
S Experience working with TUV SUD or Rheinland, and/or BSI Registrars and Notified Bodies 5
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L BSI White Paper on Human Factors/Usability Engineering IEC 62366 - Medical Device Usability Engineering 12
P What qualifications are required to become an auditor for a CB (BSI, for example)? Career and Occupation Discussions 4
S BSI's ISO 13485 certificate does not mention AC 2009 corrigendum Registrars and Notified Bodies 5
A BSI Diploma Quality Management Course ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M BSI-Free webinars Book, Video, Blog and Web Site Reviews and Recommendations 0
S Observation from BSI Audit of our Internal Audit Plan Internal Auditing 8
Coury Ferguson BSI receives AS9104/1 ANAB Accreditation - October 2012 Registrars and Notified Bodies 0
B Bureau Veritas Certification Body: SAI global ?BSI? Registrars and Notified Bodies 5
L BSI Logo - Requirements when using the BSI logo to show certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
G Does BSI do ISO 9001/TS 16949 Lead Auditor training? Training - Internal, External, Online and Distance Learning 5
Howard Atkins BSI changes accreditation - ANAB will provide accreditation services to BSI Registrars and Notified Bodies 34
Manix BSI Management System Webinars 2008 Training - Internal, External, Online and Distance Learning 13
Sidney Vianna New customer service guidelines from BSI - BS 8477 Various Other Specifications, Standards, and related Requirements 0
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A BSI ISO 9001 Lead Auditor Course registration number? Registrars and Notified Bodies 2
D MSA and Number of operators - BSI auditor: 3 operators must be used for Gage R&R Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 10
I ISO 20000 IT Service Management Standard published - Based on BSI standard BS 15000 Other ISO and International Standards and European Regulations 0
1 Recommended!! For TS16949 Certification through BSI IATF 16949 - Automotive Quality Systems Standard 6
S BSI ISO/TS 16949:2002 Requirements to Management System Matrix Form Help Registrars and Notified Bodies 4
B BSI PreAssessment Visit ISO 94-2000 - What to expect? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
D What is OHSAS 18001? An auditable Occupational Health & Safety System standard - BSi Occupational Health & Safety Management Standards 17
M BSI-CEEM RAB approved ISO 9001:2000 Lead Auditor Course General Auditing Discussions 6
Marc BSI and OSHA Web Site Various Other Specifications, Standards, and related Requirements 1
R TR 16949 - BSI Projectline Database IATF 16949 - Automotive Quality Systems Standard 11
A MDR requirement where unit of use packaging is too small for UDI carrier EU Medical Device Regulations 1
S MDR GSPR Standards EU Medical Device Regulations 0
A MDR - Legacy Device Review Timeframe and Requirements EU Medical Device Regulations 3
J Translation requirements for the statement referred to in ANNEX XIII of MDR EU Medical Device Regulations 0
J EU MDR GSPR 10.4.3 and 10.4.4 EU Medical Device Regulations 2
F Labelling to comply with both FDA and MDR US Food and Drug Administration (FDA) 6
N EU MDR and its impact on existing Registrations EU Medical Device Regulations 1
M Post Market Safety Update Report for devices that will be up-classified under MDR but are currently under MDD EU Medical Device Regulations 3
Y MDR Transition - make "Available on the market" after CE certificate expiration EU Medical Device Regulations 2
C MDR Classification Rule 10 EU Medical Device Regulations 13
C MDR software classification EU Medical Device Regulations 12
Y MDR requirements for Class I accessories EU Medical Device Regulations 2
M MDR legal actions - manufacturers CE Marking (Conformité Européene) / CB Scheme 8
R Products not within the MDR grace period EU Medical Device Regulations 1
shimonv MDR transition checklist EU Medical Device Regulations 0
K Re-packaging under MDR EU Medical Device Regulations 3

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