IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes (Edition 4) – Annex А (Edition 3), G
Posts published in July 2019
Preventing Medical Device Shortages by Ensuring Safe and Effective Sterilization in Manufacturing Device Shortages Update: The FDA Announces Two New Innovation Challenges on Device Sterilization…
How the FDA Uses Science to Speed Medical Device Innovation
US FDA Develops and Qualifies First Non-Clinical Assessment Model Tool as Part of the MDDT Program – MDDT SUMMARY OF EVIDENCE AND BASIS OF QUALIFICATION…
Danish Medicines Agency strengthens its policy on conflicts of interest
Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8
Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials
Application du règlement européen relatif aux dispositifs médicaux : l’ANSM met en place une phase pilote pour la partie investigations cliniques – Point d’information
Long-term active surveillance of implantable medical devices: an analysis of factors determining whether current registries are adequate to expose safety and efficacy problems
UL International (UK) Ltd. (NB 0843) – Medical Device Notified Body Ceasing Operation In the UK