Are You Over-Committing on Your EU MDR Post-Market Surveillance Plan?
All MedTech companies face increased post-market surveillance (PMS) requirements under the EU MDR and IVDR. A PMS plan will incorporate a Post-Market…
20 Nov 2025
Classifying Software as Medical Device in EU MDR
Introduction to Software as a Medical Device in MDR The MDCG’s Guidance document defines the criteria for software qualification falling within the…
20 Nov 2025
Annual Safety Report: Clinical Trial Reporting Requirements in EU Countries – CiteMed
Introduction Clinical trials are a fundamental component of medical product development, providing a controlled environment to evaluate the safety and performance of…
20 Nov 2025
Analyzing the Differences between CERs for MDR versus MDD
Implementing the MDR or Medical Device Regulation will bring significant changes to the process of Clinical Evaluation and subsequent post-market compliance requirements.…
20 Nov 2025
EU MDR Checklist : Compliance Essentials for Medical Device Manufacturers
The Medical Device Regulation (MDR) has been a regulatory framework since 2017. The MDR is designed to ensure that medical devices are…
20 Nov 2025
EU MDR Cybersecurity: Safeguarding Medical Devices in the Digital Age
In the fast-paced world of healthcare, there are always concerns regarding any new medical device. The concern about cybersecurity in medical devices…
20 Nov 2025
Publishing Clinical Trials Results in Journals
Clinical trials are a crucial piece of launching a medical device. Publishing the data you have gathered regarding the safety and effectiveness…
20 Nov 2025
An Overview of the CE Marking Process in the European Union
You want to sell your device in the European Union and start the CE marking process. But after reviewing the MDR and…
20 Nov 2025