Expert in medical device standards and CE regulations
This expertise is gained in over 25 years working in various roles in the medical device industry, including 10+ years as a notified body contract Lead Auditor for DEKRA.
Read more about usRob UdoConsultant
News
-
2 May 2022Update MDSAP Audit Approach MDSAP AU P0002.007
This revision includes the changes in Canadian adverse events and advisory notices reporting that took effect on June 23, 2021. Additionally, there ....
Read more -
27 April 2022MDCG 2022-05 Guideline on borderline products
This guidance covers all products on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices.
Read more -
25 January 2022
The importance of the device label to a global UDI system
The importance of the device label to a global UDI system
Read more