FDA Software Presentation – Compliance Science

The slides from a presentation by FDA’s Device Center Software and Part 11 Compliance expert (John Murray) are attached. These were presented at a conference on March 19 and reflect some of the contents and concepts of internal FDA training on software regulation. The title of the presentation is Compliance Science and it focuses on critical thinking, flexibility and risk focus as does the newly released AAMI TIR36 with which John Murray was involved.

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020

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

To pre-register and get info on deep discounts or if you have questions, email training@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.