EU – Manufacturer incident report (MIR) for serious incident- template 2020 (Directives and new regulations) version 7.2 Manufacturer incident report Helptext 2020 Manufacturer incident report…
Posts published in September 2019
Application form – Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05) Procedural guidance on…
Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices
Consultation: Review of the regulation of certain self-testing IVDs in Australia
TGA business plan 2019-20
Clinical Decision Support Software
Final and update guidances – Software … the FDA is issuing a final guidance, Changes to Existing Medical Software Policies Resulting from Section 3060 of the…
QSR/ISO 13485 Harmonization Update: FDA Enforcement Discretion Likely When New Rule Stands Up; Draft Reg Coming By Year’s End; Town Halls Planned
MDCG 2019-9 Summary of safety and clinical performance A guide for manufacturers and notified bodies – August 2019
DSVG 04 – Breast Implants – Guidance on the vigilance system for CE-marked medical devices