An Overview of the CE Marking Process in the European Union
You want to sell your device in the European Union and start the CE marking process. But after reviewing the MDR and…
20 Nov 2025
Fundamentals of Clinical Evaluation Reports: A Beginner’s Guide
The clinical evaluation reports are the final transcript for medical devices. Allow us to explain. So, you know how in high school,…
20 Nov 2025
Medical Device Development: When Should you do Clinical Evaluation?
The medical device development process is not a one-step operation. Instead, it is a multi-phase process requiring meticulous planning and implementation so…
20 Nov 2025
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 typically takes…
20 Nov 2025
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…
20 Nov 2025
Literature Search Protocol for EU MDR: When and How to Update Your Review
Getting the long-awaited CE mark is certainly something to celebrate, so if you got it, congratulations! Now you just have to make…
20 Nov 2025
Switzerland’s Medical Device Regulation and the EU Regulations
The medical device industry is thriving globally. Not only in European Union countries, but the influence is also seen in neighboring countries…
20 Nov 2025
Updates To The EU Blue Guide: Impacts on Market Surveillance of Medical Devices
For medical devices specifically, the 2022 Blue Guide doesn't add much that MDR and IVDR don't already cover in more detail. It updated the market surveillance…
20 Nov 2025