Systematic Literature Review Course
Welcome to the Systematic Literature Review Course!
Understanding Global Regulatory Authorities in the Medical Device Industry
You know what is common in all countries? No matter the geographical position, the culture, the people or religion? [...]
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 [...]
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 [...]
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, [...]
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 [...]
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 [...]
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 two sides of the [...]
Is MDR Compliance Expensive?
The short answer is, yes, it can be. MDR compliance may not have been expensive in the past, but [...]
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 [...]