Informational EU – Draft Functional specifications for the European Database on Medical Devices (Eudamed) – First release (High(1)) to be audited

Thread starter Similar threads Forum Replies Date
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Draft Guidance – Breast Implants – Certain Labeling Recommendations to Improve Patient Communication Medical Device and FDA Regulations and Standards News 0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 IMDRF draft document – Principles and Practices for Medical Device Cybersecurity Medical Device and FDA Regulations and Standards News 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M Informational US FDA Draft Guidance – Clinical Decision Support Software Medical Device and FDA Regulations and Standards News 0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M Informational US FDA Draft Guidance – Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal F Medical Device and FDA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M Informational US FDA Draft Guidance – Patient Engagement in Design and Conduct of Medical Device Clinical Investigations Medical Device and FDA Regulations and Standards News 0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M Informational FDA draft guidance – Safer Technologies Program for Medical Devices Medical Device and FDA Regulations and Standards News 0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 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M Informational US FDA draft guidance – Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment Medical Device and FDA Regulations and Standards News 0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 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
K Computerized system Master Validation Plan, IQ-OQ-PQ Draft or Template Qualification and Validation (including 21 CFR Part 11) 4
A Where to find a Draft Copy of IATF 16949:2016? IATF 16949 - Automotive Quality Systems Standard 23
SteveK 'Clean' Draft Medical Device Regulations Published EU Medical Device Regulations 0
Ronen E FDA releases new draft guidance on when to submit a 510(k) for device modification Other US Medical Device Regulations 10
Ronen E FDA issues draft guidance on form & content of UDI Other US Medical Device Regulations 0
M AAMI draft report - Postmarket Risk Management ISO 14971 - Medical Device Risk Management 2
Ajit Basrur WHO Draft document - Regulatory Framework for Medical Devices Other Medical Device Regulations World-Wide 0
Ronen E FDA issues draft guidance on additive manufacturing Other US Medical Device Regulations 1
bio_subbu USFDA issues draft Guidance on the Acceptance of Medical Device Clinical Data Other US Medical Device Regulations 1
R 510(k) Draft Guidance issued: 2011 vs 2014 - Appendix C. 510(k) Process diagram gone US Food and Drug Administration (FDA) 1
J Draft Guidance document compliance mandatory to avoid a RTA? Other US Medical Device Regulations 2
M New FDA Draft Guidance on 510(k) Ownership and Use Other US Medical Device Regulations 3
J Legal source to purchase a copy of the 9001:2015 Draft ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R New Draft Guidance Document for FDA's current thinking on De Novo submission Other US Medical Device Regulations 1
M Interpretation of Plus/Minus Draft - Injection Molded Parts Inspection, Prints (Drawings), Testing, Sampling and Related Topics 10

Similar threads

Top Bottom