Systematic Literature Review Course
Welcome to the Systematic Literature Review Course!
Your Medical Device Got CE Marked – Now What?
Obtaining the CE mark is one of the most significant milestones in the life of most medical devices. Unfortunately, it [...]
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 [...]
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 [...]
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 [...]
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 [...]
Essentials for Your EU MDR Checklist
The Medical Device Regulation (MDR) has been a regulatory framework since 2017. The MDR is designed to ensure that [...]
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 [...]
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 [...]
7 Qualities of a Fantastic Medical Writer
Medical writers make up much of the medical device regulatory industry. In fact, they are one of the largest [...]