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…
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New MedDO Amendments Implemented by Federal Council
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…
Standardizing Adverse Event Reporting: IMDRF Terminology
Despite having been published over three years ago, many manufacturers marketing their devices in IMDRF within the…
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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