Navigating Medical Device Safety, Regulation, and Adverse Europe
Adverse Events in Europe The landscape of medical device safety in Europe is significantly [...]
Tips and Tricks for How to Conduct a Literature Review with Endnote
The literature review is a critical part of any clinical evaluation. It's where you [...]
Your Medical Device Got CE Marked – Now What?
Obtaining the CE mark is one of the most significant milestones in the life [...]
Medical Device Development: When Should you do Clinical Evaluation?
The medical device development process is not a one-step operation. Instead, it is a [...]
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 [...]
EU MDR Clinical Evaluation Requirements – Understanding the CER
EU MDR Clinical Evaluation Requirement – Understanding the CER A critical component of the [...]
Fundamentals of Clinical Evaluation Reports: A Beginner’s Guide
The clinical evaluation reports are the final transcript for medical devices. Allow us to [...]
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 [...]
Switzerland’s Medical Device Regulation and the EU Regulations
The medical device industry is thriving globally. Not only in European Union countries, but [...]
Using the IMDRF Classification to Apply Rule 11
The MDCG Guidelines recommend the application of the International Medical Device Regulators Forum (IMDRF) [...]