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…
Posts published in “Day: July 22, 2019”
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
Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products — Content and Format Guidance for…
September 10, 2019: Patient Engagement Advisory Committee Meeting Announcement
LA AEMPS COMIENZA EL PROCESO PARA SER DESIGNADA COMO ORGANISMO NOTIFICADO DE ACUERDO AL MDR