EU MDR 8 min read

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…

By CiteMed Author

20 Nov 2025

Are You Over-Committing on Your ER MDR Post-Market Surveillance Plan

EU MDR 7 min read

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…

By CiteMed Author

20 Nov 2025

EU MDR 6 min read

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…

By CiteMed Author

20 Nov 2025

EU MDR Clinical Evaluation Requirements – Understanding the CER (1)

EU MDR 7 min read

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…

By CiteMed Author

20 Nov 2025

EU MDR 5 min read

Medical Device Development: When Should you do Clinical Evaluation?

The medical device development process is not a one-step operation. Instead, it is a multi-phase process requiring meticulous planning and implementation so…

By CiteMed Author

20 Nov 2025