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
Clinical Evaluation Report (CER) vs. Periodic Safety Update Report (PSUR)
Every medical device on the European market must be continuously monitored to confirm its safety and efficiency for patients and users. The…
20 Nov 2025
EU IVDR Regulation: A Brief
IVDR is a separate regulation compared to the European medical devices regulation. However, it is closely associated with the regulatory authority. The…
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
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
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
Navigating Global Medical Device Regulations
Understanding the Landscape of Global Medical Device Regulations The global landscape of medical device regulations is as diverse as it is complex.…
20 Nov 2025
In Vitro Diagnostic Regulation (IVDR) Device Risk Management Challenges
All medical devices have their merit since all of them are used in the medical field. However, the In vitro diagnostic tools…
20 Nov 2025