PMCF for IVDR and MDR – A Case Study and How-To
By now, most of us have struggled through at least one successful submission for MDR/IVDR, and we know they take time. Very…
20 Nov 2025
Unpacking State-of-the-art: Why Does It Matter to My Medical Device Clinical Evaluation?
The European Medical Device Regulation (EU MDR, 2017/745) has been called many things since it was first drafted, some of which cannot…
20 Nov 2025
5 Major Concerns for Software As a Medical Device and AI Companies
Move over, Dr House, there's a new diagnostician in town, and it's not human! Thanks to the power of AI, medical devices…
20 Nov 2025
Using the IMDRF Classification to Apply Rule 11
The MDCG Guidelines recommend the application of the International Medical Device Regulators Forum (IMDRF) risk categorization framework to help with risk classification…
20 Nov 2025
Managing Clinical Evaluation Report (CER) and Literature Review Teams
Being a medical device manufacturer involves more than the actual manufacturing of the medical devices. A manufacturer's job is not only to…
20 Nov 2025
Post-Market Surveillance and Vigilance: MDR vs IVDR
PMS and vigilance are two halves of the same post-market system. PMS is the manufacturer's proactive, continuous collection and review of data…
20 Nov 2025
Is MDR Compliance Expensive?
The short answer is, yes, it can be. MDR compliance may not have been expensive in the past, but as the regulations…
20 Nov 2025
Updates of the MDCG 2019 9 Rev 1, SSCP, and Others
The term summary of safety and clinical performance has recently sent the medical manufacturing world into a buzz. The new MDCG 2019…
20 Nov 2025