Systematic Literature Review Course
Welcome to the Systematic Literature Review Course!
12 EU MDR Guidance Documents You Need
EU MDR is undoubtedly a fantastic way of upgrading the medical device market quality, but the process is anything [...]
Market Surveillance of Medical Devices Under the EU MDR
The term market surveillance covers the activities carried out by national regulatory authorities to ensure the safety and efficiency of [...]
Updating the Literature Review and Literature Search Protocol
Getting the long-awaited CE mark is certainly something to celebrate, so if you got it, congratulations! Now you just [...]
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 [...]
EU MDR Clinical Evaluation Requirements – Understanding the CER
EU MDR Clinical Evaluation Requirement – Understanding the CER A critical component of the Technical File Submission for the [...]
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 collect all of your clinical [...]
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 [...]
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 [...]
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 [...]