IMDrf Finalizes SaMD Document

The IMDRF Management Committee approved the final N12 document, “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations”. IMDRF publishes their documents at the link provided. This document should be posted in the near future. FDA participates actively in the International Medical Device Regulators Forum (IMDRF) which is seeking to harmonize international regulation.

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT

Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)!  Email
to receive discount

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
Registration Link

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.