Carefully Curated Publications for MedTech clinical teams
Continuously updated publications developed by medical device industry experts to help study sponsors simplify their clinical studies
Ultimate Guide to Device Class Requirements under EU MDR
An in-depth guide on EU MDR medical device classification and requirements
In order to earn a CE marking, medical device companies need to comply with the legislation's numerous safety, technical, and post-market requirements. This can be an extremely challenging process, particularly for companies new to marketing devices in the European Union.
That is why we have created this guide. Along with instructions on how to classify and categorize your devices, you’ll learn exactly what you need to know when it comes to:
Preparing technical documentation (what, and when to submit), including PSURs, PMCFs, and SSCPs
Conducting clinical evaluations and collecting clinical data
Although new and innovative devices can transform healthcare, there’s a growing need to regulate the MedTech industry - not only to protect the patients but to leverage its full potential. Request your copy and learn:
The most notable changes of the MDR
What to consider in terms of new clinical requirements
How to Design an Electronic Case Report Form (eCRF)
Design better forms, save time and lower costs
With better designed forms, we’ve seen increased compliance rates, better data quality, and better communication between study participants. This has lead to decreased time spent on data management, which results in lowered costs, and eventually shorter time to market. Request your copy and learn:
The 7 principles of an optimal eCRF design process.