Classifying Software as Medical Device in EU MDR
Introduction to Software as a Medical Device in MDR The MDCG's Guidance document defines [...]
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 [...]
Essentials for Your EU MDR Checklist
The Medical Device Regulation (MDR) has been a regulatory framework since 2017. The MDR [...]
Best Systematic Literature Review Software
A systematic literature review is one of the most important stages of the CER process, [...]
Performance Plan Evaluation Under the EU IVDR 2017/746
Most of us are familiar with clinical evaluations for medical devices. Easy peasy. But [...]
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 [...]
Navigating Global Medical Device Regulations
Understanding the Landscape of Global Medical Device Regulations The global landscape of medical device [...]
Top 10 Literature Search Tools Every Medical Writer Should Know
Medical writing is hard. It's tricky, technical, and sometimes exceptionally tedious. Suppose you chose literature [...]
Vigilance Reporting Under the MDR: Insider’s Guide
Implementing the European Medical Devices Regulation (MDR; 2017/745) and the In Vitro Diagnostic Medical Devices [...]
EU Clinical Trial Regulation: What you Need to Know
For manufacturers, clinical trials or at least the protocol are already planned [...]
