Informational IMDRF draft document – Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews

Highly Rated Gage Tracking - Learn More
Elsmar Forum Sponsor
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Informational IMDRF draft document – Principles and Practices for Medical Device Cybersecurity Medical Device and FDA Regulations and Standards News 0
M Informational TGA-led IMDRF Personalised Medical Devices working group meets in Canberra Medical Device and FDA Regulations and Standards News 0
S IMDRF or still GHTF for STED and other guidance? Other Medical Device and Orthopedic Related Topics 5
M Informational IMDRF proposed document – IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes (Edition 4) – Anne Medical Device and FDA Regulations and Standards News 0
J MEDDEV 2.12/1's new MIR & IMDRF terms & codes (IMDRF Annex) EU Medical Device Regulations 1
M Informational IMDRF Consultation – Personalized Medical Devices – Regulatory Pathways Medical Device and FDA Regulations and Standards News 0
M Informational IMDRF – Proposed update to Clinical Evaluation documents Medical Device and FDA Regulations and Standards News 0
M Informational CDRH Proposes New IMDRF Work Item on Standards Medical Device and FDA Regulations and Standards News 0
M Informational IMDRF final document – Assembly and Technical Guide for IMDRF Table of Contents Submissions Medical Device and FDA Regulations and Standards News 4
M Medical Device News IMDRF update - 26-09-18 - Cybersecurity, Premarket Reviews, Personalized Devices Other Medical Device Regulations World-Wide 0
F IMDRF opened a Consultation on Annex E & F and the link to ISO 14971 ISO 14971 - Medical Device Risk Management 4
T MEDDEV 2.7/1 r4 vs. IMDRF/SaMD WG/N41 Other Medical Device Related Standards 3
H GHTF and IMDRF - Alternative for the STED format EU Medical Device Regulations 5
S NB-MED, NBOG, IMDRF and MEDDEV hierarchy EU Medical Device Regulations 3
M IMDRF document - Application of QMS to SaMD ISO 13485:2016 - Medical Device Quality Management Systems 2
W IEC 62304 vs. IMDRF SaMD Guideline Risk Class IEC 62304 - Medical Device Software Life Cycle Processes 5
P IMDRF (International Medical Devices Regulators Forum)guidance on standalone software Medical Information Technology, Medical Software and Health Informatics 1
AnaMariaVR2 IMDRF Working With ICH on Harmonized Electronic Submission System for Drugs, Devices Other Medical Device Regulations World-Wide 0
Ajit Basrur IMDRF inviting comments on Audit Program and UDI ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 0
Ronen E IMDRF Feb/Mar 2012 Meeting - Outcome Statement Other Medical Device Regulations World-Wide 9
Ajit Basrur GHTF evolves into International Medical Device Regulators' Forum (IMDRF) Other Medical Device Regulations World-Wide 0
dgrainger Informational DRAFT - Common specifications for the groups of products without an intended medical purpose listed in Annex XVI. EU Medical Device Regulations 0
Watchcat New Draft Guidance on Content of Premarket Submissions for Software Device "Functions" Other US Medical Device Regulations 2
J Can we register non-device clinical decision support software under draft guidance? Other US Medical Device Regulations 5
dgrainger Informational DRAFT: The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 UK Medical Device Regulations 1
dgrainger Informational DRAFT: The Medical Devices (Northern Ireland Protocol) Regulations 2021 UK Medical Device Regulations 1
T Draft of New UK Regulations? UK Medical Device Regulations 2
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Draft Guidance – Breast Implants – Certain Labeling Recommendations to Improve Patient Communication Medical Device and FDA Regulations and Standards News 0
C FMEA Process assessment In the Draft for the AIAG/VDA FMEA Manual is gone FMEA and Control Plans 0
M Informational US FDA Draft Guidance – Clinical Decision Support Software Medical Device and FDA Regulations and Standards News 0
M Informational From Medtech Insight – QSR/ISO 13485 Harmonization Update: FDA Enforcement Discretion Likely When New Rule Stands Up; Draft Reg Coming By Year’s End; Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Draft Guidance – Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal F Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Draft Guidance – Patient Engagement in Design and Conduct of Medical Device Clinical Investigations Medical Device and FDA Regulations and Standards News 0
M Informational Several US FDA draft guidances, including some specific device guidances for the Safety and Performance Based Pathway Medical Device and FDA Regulations and Standards News 0
M Informational FDA draft guidance – Safer Technologies Program for Medical Devices Medical Device and FDA Regulations and Standards News 0
M Informational US FDA draft guidance – Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment Medical Device and FDA Regulations and Standards News 0
M Informational EU draft act – Single-use medical devices – safety and performance requirements for reprocessing Medical Device and FDA Regulations and Standards News 0
M Informational Draft ANSM’S GUIDELINE Cybersecurity of medical devices integrating software during their life cycle Medical Device and FDA Regulations and Standards News 0
M Informational Draft standardisation request as regards medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Medical Device and FDA Regulations and Standards News 2
M Informational US FDA draft guidance. – Clinical Investigations for Prostate Tissue Ablation Devices Medical Device and FDA Regulations and Standards News 2
M Informational US FDA draft guidance – Mouse Embryo Assay for Assisted Reproduction Technology Devices Medical Device and FDA Regulations and Standards News 0
L Getting Notice of Revision and Accessing Public Draft Copies of ISO Standards Service Industry Specific Topics 2
M Informational EMA – Consultation on draft guideline on quality requirements for medical devices in combination products Medical Device and FDA Regulations and Standards News 0
M Informational USFDA draft guidance – Technical Performance Assessment of Quantitative Imaging in Device Premarket Submissions Medical Device and FDA Regulations and Standards News 0
M Informational USFDA draft guidance – Technical Considerations for Non- Clinical Assessment of Medical Devices containing Nitinol Medical Device and FDA Regulations and Standards News 0
M Informational USFDA Draft Guidance – Review and Update of Device Establishment Inspection Processes and Standards Medical Device and FDA Regulations and Standards News 0
M Informational USFDA draft guidance – A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry Medical Device and FDA Regulations and Standards News 0
M Informational EU – Draft Functional specifications for the European Database on Medical Devices (Eudamed) – First release (High(1)) to be audited Medical Device and FDA Regulations and Standards News 0
M Dynamic Control Plan Draft - need review FMEA and Control Plans 2

Similar threads

Top Bottom