Is MDR Compliance Expensive?
The short answer is, yes, it can be. MDR compliance may not have been [...]
Post-Market Surveillance and Vigilance: MDR vs IVDR
The Medical Device Regulation 2017/745 (MDR) and the In Vitro Diagnostic Regulation 2017/746 (IVDR) are [...]
Managing Clinical Evaluation Report (CER) and Literature Review Teams
Being a medical device manufacturer involves more than the actual manufacturing of the medical [...]
Using the IMDRF Classification to Apply Rule 11
The MDCG Guidelines recommend the application of the International Medical Device Regulators Forum (IMDRF) risk [...]
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 [...]
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 [...]
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 [...]
Understanding Global Regulatory Authorities in the Medical Device Industry
You know what is common in all countries? No matter the geographical position, the [...]
EU MDR: Combination Products – An Overview
We all know and love (ahem) the EU MDR (2017/745). And although it is [...]
Fundamentals of a Literature Review: A Beginner’s Guide
The medical device industry is fueled by innovation. Research and development are the blood [...]
