Unexpected Documents You Might Need for Your Clinical Evaluation Report
Medical device regulation is important. Not just because we work with them. But because they control and regulate devices that diagnose, treat,…
20 Nov 2025
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 )…
20 Nov 2025
Your MDR Readiness Checklist
The new EU MDR Regulations Everything you needed to know in 2020 The final period for compliance with EU medical device regulation…
20 Nov 2025
CER Medical Writer Qualifications for EU MDR: 7 Essential Skills
A strong CER medical writer combines the right academic background, real regulatory experience, and precise technical writing, and meets the specific qualification…
20 Nov 2025
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…
20 Nov 2025
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…
20 Nov 2025
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…
20 Nov 2025
Annual Safety Report: Clinical Trial Reporting Requirements in EU Countries – CiteMed
Introduction Clinical trials are a fundamental component of medical product development, providing a controlled environment to evaluate the safety and performance of…
20 Nov 2025