SBS - The best value in QMS software

Informational IMDRF – Proposed update to Clinical Evaluation documents

Quickly Organize an Intelligent TDP from DISCUS
Elsmar Forum Sponsor
You must log in or register to reply here.
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 5
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
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
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
qualprod 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