EU MDR

EU MDR 6 min read

Quality Management System: What ISO Standards Say About QMS

A quality management system is a huge part of producing medical devices. Whether you like the process or not, a well-designed and…

By CiteMed Author

20 Nov 2025

EU MDR 6 min read

Medical Device Regulations – Links You Should Be Aware Of

Medical device regulations are no joke. It's pretty important to get the regulations right, since even a single missed data, if significant…

By CiteMed Author

20 Nov 2025

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 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 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 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

EU MDR 6 min read

CER Medical Writer Qualifications for EU MDR: 7 Essential Skills

Medical writers make up much of the medical device regulatory industry. In fact, they are one of the largest contributors behind the…

By CiteMed Author

20 Nov 2025

EU MDR 7 min read

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.…

By CiteMed Author

20 Nov 2025