Classifying In Vitro Diagnostic Medical Devices Under The MDR
May 26, 2022, marks the start of the 5-year staggered implementation of the In Vitro [...]
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 [...]
Updates To The EU Blue Guide: Impacts on Market Surveillance of Medical Devices
In July 2021, Regulation (EU) 2019/1020 on market surveillance and product compliance, issued by [...]
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 it, [...]
Navigating Medical Device Safety, Regulation, and Adverse Europe
Adverse Events in Europe The landscape of medical device safety in Europe is significantly [...]
The Post-Market Surveillance Document: Which Ones Do you Need?
It's not enough to make a device and put it on the market—you must know [...]
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 [...]
Fundamentals of Clinical Evaluation Reports: A Beginner’s Guide
The clinical evaluation reports are the final transcript for medical devices. Allow us to explain. [...]
