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The Latest Guidance on CDS Software and AI-enabled Medical Devices

In our latest insight brief, Digital Health: How to Navigate Regulatory, Reimbursement and Clinical Trial Landscapes, experts from MCRA, an IQVIA business, share perspectives on aligning AI-enabled devices and clinical decision support (CDS) software development with evolving FDA expectations, reimbursement pathways and clinical trial design.

What you'll learn:

Regulatory: Key FDA guidelines for Clinical Decision Support (CDS) software, AI-enabled medical devices, and Software as a Medical Device (SaMD), with a focus on safety and efficacy.
Reimbursement: Strategies for securing coverage from CMS and commercial payers, including market access and health economics.
Clinical trials: How digital health can enhance patient enrollment, streamline admin tasks, and strengthen clinical evidence.

READ THE INSIGHT BRIEF

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