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Literature Review 10 min read

Literature Search: How Much Research is Enough?

The research process is often thought of as a linear, straightforward path. You begin with a question and then proceed to find…

By CiteMed Author

20 Nov 2025

Vigilance 6 min read

Vigilance Reporting Under the MDR: Insider’s Guide

Implementing the European Medical Devices Regulation (MDR; 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR; 2017/746) have significantly increased post-market…

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

CER Writing 6 min read

Five Practical Tips for Writing a Compliant Clinical Evaluation Report (CER)

Even for experienced medical writers and regulatory staff, writing a compliant clinical evaluation report (CER) for medical devices can be tricky. Regulations…

By CiteMed Author

20 Nov 2025

IVDR 9 min read

EU In Vitro Diagnostic Regulation (IVDR): Frequently Asked Questions

The regulatory landscape in Europe is changing. In 2021, the new medical device regulation was implemented; in 2022, it was time for…

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