WHO Draft document - Regulatory Framework for Medical Devices

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
John C. Abnet IATF rules 6th edition - Looking to access the Draft document IATF 16949 - Automotive Quality Systems Standard 8
M Informational IMDRF draft document – Principles and Practices for Medical Device Cybersecurity Medical Device and FDA Regulations and Standards News 0
J Draft Guidance document compliance mandatory to avoid a RTA? Other US Medical Device Regulations 2
R New Draft Guidance Document for FDA's current thinking on De Novo submission Other US Medical Device Regulations 1
H 4.2.3 Document Control using Microsoft Sharepoint - Visibility of Draft Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
bio_subbu FDA issues first draft guidance document on Mobile Medical Applications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
bio_subbu GHTF Issues Draft Guidance Document on UDI System for Medical Devices Other Medical Device Related Standards 1
G MDR DRAFT DoC EU Medical Device Regulations 7
dgrainger Informational Draft for comment - "reclassification of products without an intended medical purpose" EU Medical Device Regulations 6
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Watchcat New Draft Guidance on Content of Premarket Submissions for Software Device "Functions" Other US Medical Device Regulations 2
J Can we register non-device clinical decision support software under draft guidance?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M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Draft Guidance – Breast Implants – Certain Labeling Recommendations to Improve Patient Communication Medical Device and FDA Regulations and Standards News 0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
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
P Understanding FDA draft "Management of Cybersecurity in Medical Devices" Medical Information Technology, Medical Software and Health Informatics 3
M Medical Device News FDA Releases Draft Recommendations on Premarket Submissions for Management of Cybersecurity in Medical Devices Other US Medical Device Regulations 0
M Medical Device News FDA news - 05-09-18 - Draft - Uncertainty in Benefit-Risk Determinations Other US Medical Device Regulations 0
R Information on the roll out of the new harmonized DRAFT FMEA AIAG/VDA manual IATF 16949 - Automotive Quality Systems Standard 4

Similar threads

Top Bottom