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Systematic Review 6 min read

Best Systematic Literature Review Software

A systematic literature review is one of the most important stages of the CER process, but it's also time-consuming and labor-intensive. Literature…

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

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