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PRI Establishes Working Group to Improve Medical Device Quality and Supply Chain Resiliency

By MedTech Intelligence Staff
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The purpose of the Best Practices in Supply Chain Resiliency and Quality Working Group is to improve medical device quality and supply chain resiliency by expanding MedAccred adoption through the tiers in the supply chain, identifying best practices to supplement efforts in quality assurance and procurement strategies, and to help mitigate supply chain risks.

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Artificial intelligence, medical devices
Artificial intelligence, medical devices

The Regulatory Aspects of AI/ML-based SaMD

By Zuhal Reed
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Modern technology has given rise to new legal questions. How does FDA regulate machine-learning computers that are changing so rapidly – given that the approved product may be drastically different than the product that ends up on the market? These questions arise from a lack of understanding of the complex nature of AI/ML-based SaMD, the opaqueness of the regulatory framework, and a dearth of relevant case law.

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