Medical Device Development: When Should you do Clinical Evaluation?
The medical device development process is not a one-step operation. Instead, it is a [...]
Fundamentals of Clinical Evaluation Reports: A Beginner’s Guide
The clinical evaluation reports are the final transcript for medical devices. Allow us to [...]
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 [...]
EU MDR Clinical Evaluation Requirements – Understanding the CER
EU MDR Clinical Evaluation Requirement – Understanding the CER A critical component of the [...]
Switzerland’s Medical Device Regulation and the EU Regulations
The medical device industry is thriving globally. Not only in European Union countries, but [...]
Updating the Literature Review and Literature Search Protocol
Getting the long-awaited CE mark is certainly something to celebrate, so if you got [...]
Using the IMDRF Classification to Apply Rule 11
The MDCG Guidelines recommend the application of the International Medical Device Regulators Forum (IMDRF) [...]
Clinical Evaluation Assessment Report Rubric: What Does It Mean For Your MDR Submissions?
MDCG’s Guidance document, released in July 2020, introduces and details the key requirements and [...]
Classifying In Vitro Diagnostic Medical Devices Under The MDR
May 26, 2022, marks the start of the 5-year staggered implementation of the In [...]
Fundamentals of a Literature Review: A Beginner’s Guide
The medical device industry is fueled by innovation. Research and development are the blood [...]