In Vitro Diagnostic Devices Regulation (IVDR) and How It Relates to CE markings
CE marking indicates compliance with an EU directive so that you can market your [...]
Vigilance Reporting Under the MDR: Insider’s Guide
Implementing the European Medical Devices Regulation (MDR; 2017/745) and the In Vitro Diagnostic Medical [...]
MEDDEV 2.7.1 Revision 4: Guidelines for Clinical Evaluation
In accordance with the European directive for medical devices 93/42/EEC, ‘manufacturers must provide proof [...]
Your MDR Readiness Checklist
The new EU MDR Regulations Everything you needed to know in 2020 The final [...]
Building Your PMS Templates
This document intends to cover a comprehensive framework for each of your products. Use [...]
Unexpected Documents You Might Need for Your Clinical Evaluation Report
Medical device regulation is important. Not just because we work with them. But because [...]
Software as a Medical Device
Healthcare is undergoing a paradigm shift as cutting-edge technology makes its way into medical [...]
Quality Management System: What ISO Standards Say About QMS
A quality management system is a huge part of producing medical devices. Whether you [...]
In Vitro Diagnostic Regulation (IVDR) Device Risk Management Challenges
All medical devices have their merit since all of them are used in the [...]
Medical Device Regulations – Links You Should Be Aware Of
Medical device regulations are no joke. It's pretty important to get the regulations right, [...]