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FDA Regulatory Overview for Artificial Intelligence / Machine Learning /Software as a Medical Device (SaMD)
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 is now regulated by the FDA Center for Devices and Radiological Health (CDRH). FDA partnered with regulatory authorities from other countries/regio
rhl341
Jun 211 min read
Health Insurance Portability and Accountability Act of 1996 (HIPPA) Privacy Rule
BioPhia Consultant Ed Moore presents a training video as part of the Great Lakes Medical Jumpstart I-CORPS program discussing a key...
rhl341
Aug 20, 20241 min read
Biologics FDA Regulatory Overview
BioPhia Consultant Ed Moore presents a training video as part of the Great Lakes Medical Jumpstart I-CORPS program discussing the...
rhl341
Aug 20, 20241 min read
In Vitro Diagnostics Regulatory Overview
BioPhia Consultant Ed Moore presents a training video as part of the Great Lakes Medical Jumpstart I-CORPS program discussing the...
rhl341
Aug 13, 20241 min read
Medical Devices Regulatory Overview
BioPhia Consultant Ed Moore presents a training video as part of the Great Lakes Medical Jumpstart I-CORPS program discussing the...
rlang62
Jul 11, 20241 min read
Drug Products FDA Regulatory Overview
BioPhia Consultant Ed Moore presents a training video as part of the Great Lakes Medical Jumpstart I-CORPS program discussing the...
rlang62
Jul 11, 20241 min read
From Ideas to Impact: COZAD Fuels Student Startups at the New Venture Challenge
BioPhia is proud to be a long-time supporter of the University of Illinois, Champaign-Urbana campus-wide Cozad New Venture Challenge....
rhl341
Jun 25, 20241 min read
BioPhia Celebrates 10 Years
BioPhia Consulting celebrates 10 years of service and support for the medical products industry providing consulting services for R&D,...
Ed Moore
Jan 18, 20241 min read