Medical Device Software & AI – Overview
Overview
Global regulatory frameworks involving digital health technologies, particularly for the areas of medical device software including Artificial Intelligence and Machine Learning (AI/ML) are still evolving. MDIC Digital Health Program recognizes the convergence of connectivity, information and software that are revolutionizing the healthcare ecosystem, including medical device development.
Our Mission
To collaboratively and strategically advance science and evidence for high-quality digital health technologies by shaping and informing the regulatory science needed to accelerate digital health innovation, drive synergies, and advance best practices.
Medical Device Software & AI Focus Areas
Pre-determined Change Control
MDIC’s focus will be to develop a library of examples that can be utilized with the PCCP across all software types.
Software Design Considerations
This project aims to develop a framework with examples for software modification subject to PMA.
Software Submission Best Practices
The workstream is developing a list of prioritized ideas to improve efficiencies for premarket review.
Opportunity
Digital health technologies (“DHT”), including AI/ML-enabled devices, are revolutionizing the healthcare ecosystem, including medical device development. It is expected that the number of digital health technologies will increase exponentially in the future, and the global regulatory frameworks involving digital health technologies are still evolving. As such, there is a need to develop regulatory science tools to assess the device performance over time.
Project Leadership
Cassie Scherer
Senior Director of U.S. Regulatory and Global Digital Health Policy Global Regulatory Affairs, Medtronic
Meet the Team
Contact our team to get involved in all the exciting work happening now!
Jithesh Veetil, PhD
Senior Program Director | Digital Health and Technology (DHT)
Email: jveetil@mdic.org
Taylor Montgomery, MS
Project Manager | Digital Health and Technology (DHT)
Email: tmontgomery@mdic.org