Informational IMDRF draft document – Principles and Practices for Medical Device Cybersecurity

Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
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
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 4
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
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
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
M Informational Publication of Draft Health Canada Implementation Guidance for the International Medical Device Regulators Forum Table of Contents Format Medical Device and FDA Regulations and Standards News 0
Y My mission is to draft a procedure related to ISO 14155 - Good Clinical Investigation Practices Other Medical Device Related Standards 1
M Informational USFDA Draft Guidance – Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation – Non-clinical Testing and Clinical Medical Device and FDA Regulations and Standards News 0
M Informational USFDA draft guidance – Nonbinding Feedback After Certain FDA Inspections of Device Establishments Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA draft guidance – Principles of Premarket Pathways for Combination Products; Draft Guidance for Industry; Availability Medical Device and FDA Regulations and Standards News 0
S China 2018 draft Amendments to the Regulations on the Supervision and Administration of Medical Devices China Medical Device Regulations 1
M FDA News USFDA Draft Guidance – Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment Medical Device and FDA Regulations and Standards News 0
Similar threads
Top Bottom