Post Market Clinical Follow Up Medical Devices: Requirements and Key Methods Under EU MDR
The core PMCF templates, MDCG 2020-7 for the plan and MDCG 2020-8 for the evaluation report, are still current as of this…
20 Nov 2025
CER for Software as a Medical Device in the EU
The medical device industry has been changing bit by bit every day, and one of the significant changes is the addition of…
20 Nov 2025
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 products in the EU. It's that simple. CE…
20 Nov 2025
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 of and document the performance and safety of…
20 Nov 2025
Your MDR Readiness Checklist
The new EU MDR Regulations Everything you needed to know in 2020 The final period for compliance with EU medical device regulation…
20 Nov 2025
Building Your PMS Templates
This document intends to cover a comprehensive framework for each of your products. Use it as a guide to direct your staff…
20 Nov 2025
Unexpected Documents You Might Need for Your Clinical Evaluation Report
Medical device regulation is important. Not just because we work with them. But because they control and regulate devices that diagnose, treat,…
20 Nov 2025
Software as a Medical Device (SaMD): EU MDR and FDA Regulatory Overview
Healthcare is undergoing a paradigm shift as cutting-edge technology makes its way into medical devices, tele-health, and digital health solutions. Most modern…
20 Nov 2025