The latest guidance on CDS software and AI-Enabled medical devices
Unlock insights for regulatory, market access and clinical success.
In the rapidly evolving world of digital health, staying ahead of regulatory, reimbursement, and clinical trial challenges is crucial. Our latest insight brief, "Digital Health: How to Navigate Regulatory, Reimbursement, and Clinical Trial Landscapes for Clinical Decision Support and Medical Device Software," offers strategic guidance to help digital health innovators succeed.
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.
Why This Insight Brief is Essential:
- Expert Insights: Authored by industry leaders Michael Anselmo, Alex Cadotte, Ph.D., and Kenneth Rayl from MCRA - an IQVIA business.
- Strategic Guidance: Empower your innovation with practical advice on maximizing digital health technologies for better patient outcomes.
- Case Studies: Real-world examples of how digital health technologies have dramatically improved clinical trial recruitment and outcomes.
Download the Insight Brief
Stay ahead in the digital health landscape with our comprehensive insight brief. Fill out the form below to access your copy.
