IMDRF Standards Checklist modified in scope of COVID-19
Posts published in “International Medical Device Regulators Forum – IMDRF”
Regulatory Authority Assessment Method for Recognition and Surveillance of Medical Device Conformity Assessment Bodies
So new draft agendas were published for some of the next MDCG meetings. Here are some topics that caught my attention (besides the important general…
Coronavirus Prompts IMDRF to Cancel 3 Meetings
IMDRF Final Documents – Clinical Evidence, Clinical Evaluation and Clinical Investigation
TGA-led IMDRF Personalised Medical Devices working group meets in Canberra
IMDRF Principles and Practices for Medical Device Cybersecurity
IMDRF draft document – Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews
IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes (Edition 4) – Annex А (Edition 3), G
Personalized Medical Devices – Regulatory Pathways