Market Surveillance of Medical Devices Under the EU MDR
The term market surveillance covers the activities carried out by national regulatory authorities to [...]
12 EU MDR Guidance Documents You Need
EU MDR is undoubtedly a fantastic way of upgrading the medical device market quality, [...]
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 [...]
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) [...]
Managing Clinical Evaluation Report (CER) and Literature Review Teams
Being a medical device manufacturer involves more than the actual manufacturing of the medical [...]
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! [...]
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 [...]