Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR
Medical Device Expert News
Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling
Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings – Labeling Considerations
Regulation (EU) 2017/746 on in vitro diagnostic medical devices – NB 0124 DEKRA Certification GmbH Germany
ISO TC 210 JWG 1 “finished” today the monumental task we’ve been working for the past 3 years – the revision of ISO 14971 and…
MEDSAFE – Medical Device Adverse Event Reporting
Another series, initiated in a Linkedin post. The PMS process is nothing more than a research project focused on answering specific questions related to the…
Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC
State-of-play of joint assessments of Notified Bodies in the medical device sector
IMDRF Principles and Practices for Medical Device Cybersecurity