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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 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 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

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

IVDR 5 min read

Performance Plan Evaluation Under the EU IVDR 2017/746

Most of us are familiar with clinical evaluations for medical devices. Easy peasy. But when it comes to the equivalent for in vitro…

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 13 min read

Navigating Medical Device Safety, Regulation, and Adverse Europe

Adverse Events in Europe The landscape of medical device safety in Europe is significantly influenced by the occurrence and management of adverse…

By CiteMed Author

20 Nov 2025