Navigating Global Medical Device Regulations
Understanding the Landscape of Global Medical Device Regulations The global landscape of medical device regulations is as diverse as it is complex.…
20 Nov 2025
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…
20 Nov 2025
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…
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
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…
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
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
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