top of page

Regulatory Path for Artificial Intelligence / Machine Learning (Software as a Medical Device (SaMD))

shelleyamaves

Updated: Sep 18, 2023





BioPhia Consultant Ed Moore presents a training video as part of the Great Lakes Medical Jumpstart I-CORPS program discussing the regulatory paths associated with Artificial Intelligence/ Machine Learning or Software as a Medical Device (SaMD).


Software as a Medical Device (SaMD) is a relatively new area of medical devices that are now regulated by FDA (CDER). FDA partnered with regulatory authorities from other countries/regions to create the International Medical Device Regulatory Forum (IMDRF) which is a risk-based approach to determine validation guidance, quality systems, and clinical requirements for SaMD products.

26 views0 comments

Recent Posts

See All

Kommentarer


© 2024 BioPhia Consulting 

100 S. Saunders Road #111813 Suite 150, Lake Forest, IL 60045 info@biophia.com

  • LinkedIn

Powered and secured by Wix

bottom of page