Informational IMDRF – Proposed update to Clinical Evaluation documents

Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
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
M Informational TGA-led IMDRF Personalised Medical Devices working group meets in Canberra Medical Device and FDA Regulations and Standards News 0
M Informational IMDRF draft document – Principles and Practices for Medical Device Cybersecurity 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 4
M Informational IMDRF draft document – Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews 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 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
SteveK 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
S Proposed Quality Improvement - Thoughts? Medical Device and FDA Regulations and Standards News 3
M Informational US FDA – CDRH Proposed Guidances for Fiscal Year 2020 (FY 2020) Medical Device and FDA Regulations and Standards News 0
P Proposed revision of IEC 62304 - 2019 IEC 62304 - Medical Device Software Life Cycle Processes 6
M Informational TGA Consultation: Proposed clarification of the regulatory requirements for medical device systems and procedure packs Medical Device and FDA Regulations and Standards News 2
M Informational TGA Consultation: Proposed changes to medical device essential principles for safety and performance Medical Device and FDA Regulations and Standards News 0
Q Proposed Kpis ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Watchcat Informational Proposed Rule - De novos - 2019 Other US Medical Device Regulations 1
M Informational US FSA – Surgical staples – Guidance and proposed rules Medical Device and FDA Regulations and Standards News 0
M Informational TGA – Several proposed changes to classification to better align with the EU MDR Medical Device and FDA Regulations and Standards News 0
M Informational TGA Consultation: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices Medical Device and FDA Regulations and Standards News 0
T FDA proposed labeling standalone software cloud based US Food and Drug Administration (FDA) 4
M Medical Device News FDA Withdrawals Two Proposed Rules Other US Medical Device Regulations 0
M Medical Device News FDA News - 03-10-18 - CDRH FY 2019 Proposed Guidance Development and Focused Retrospective Review of Final Guidance Other US Medical Device Regulations 0
M Medical Device News Health Canada - Proposed Changes - List of Recognized Standards for Medical Devices Canada Medical Device Regulations 3
Sidney Vianna Proposed Change to 3rd Party Audit Process - Limiting Scope of Audit Registrars and Notified Bodies 19
M Proposed System: Revision = Modification Date; Approval = Access Permissions Document Control Systems, Procedures, Forms and Templates 1
M Updates on proposed EU Medical Device Regulations - June 2016 EU Medical Device Regulations 20
E Status of proposed changes to Medical Device Directive EU Medical Device Regulations 0
Ajit Basrur New Guideline from ICH proposed on Lifecycle Management - Q12 Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
L The proposed changes to ISO 14001: Better or just bigger? ISO 14001:2015 Specific Discussions 5
0 Feedback on proposed restructure of Quality Management System (QMS) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
Ronen E Proposed reclassification of Ultraviolet (UV) Lamps intended to tan the skin Other US Medical Device Regulations 1
P Proposed Changes to the Medical Device Directive (and IVDD) EU Medical Device Regulations 0
S Proposed FDA Board of Directors - 2013 US Food and Drug Administration (FDA) 1
D Ticketing System to Manage Five Service Lines for proposed QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Ajit Basrur FDA - CDRH Fiscal Year 2013 (FY 2013) Proposed Guidance Development US Food and Drug Administration (FDA) 0
1 510 K Webinar on Proposed Changes Other US Medical Device Regulations 4
M Proposed EU MDD (Medical Device Directive) Revision(s) - 2012 - 2013 EU Medical Device Regulations 16
S US FDA Unique Device Identification (UDI) Proposed Rule 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 18
Similar threads


















































Top Bottom