MHRA: Standalone Software and Apps

The Medicines and Healthcare Products Regulatory Agency (MHRA) guidance document: Medical device stand-alone software including apps (including IVDMDs) serves as a replacement for the previous MHRA guidance on medical device standalone software and apps. It...

Device Software and Data Collection Transparency

Decentralized clinical trials (DCTs) are becoming more and more popular as a means of improving patient access and participation, reducing costs, and increasing efficiency. However, DCTs also present unique challenges in terms of data collection and management,...
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