Clinical Investigation Under the MDR: When is it Not Mandatory?
Due to the resources necessary to perform a clinical investigation under the…
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Performing Clinical Evaluations: Article 61(10) Under the MDR
Under Article 61(10) of the MDR,…
IVD Regulations Within the UK: A Comprehensive Overview
Understanding the evolving landscape of UK IVD regulations as a manufacturer can be difficult when wanting to ensure the correct…
EU IVDR Labeling: Requirements and Best Practices
The term “labeling” in the European in vitro diagnostic medical device Regulation 2017/746…
Medical Device Risk Management: Hazards and Controls
In the ever-evolving landscape of medical technology, ensuring the safety and reliability of medical devices is paramount and even…
Trend Reporting Under the IVDR: Device Performance Issues
One of several changes introduced in the transition from the In…
EUDAMED User Guide: SSCPs and Certificates
The European Commission published the updated EUDAMED User Guide – Notified Bodies & Certificates…
MHRA Guidance on SaMDs: Navigating the Regulatory Landscape
Software as a Medical Device (SaMD) is defined as software intended to be used for one or more medical purposes…
The Role of Regulatory Affairs in Product Development
In the complex and highly regulated world of medical…
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