This document provides a summary of primary medical device standards as well as standards specific to Medical Device and Health IT software including Cybersecurity and systems and software engineering standards. It includes an assessment of how the standards will impact the development of medical device and Health IT software. This is truly a MUST READ...Read More
The US Law PLAW-114Publ255 referred to as the 21st Century Cures Act published in Dec 2016 is at the link provided. There are many important elements of this law for Drugs, Devices, and Biologics. 21st Century Cures ActRead More
“Being Agile & Compliant”
2-day Public Training Course
Tampa, Florida USA
Feb 18-19, 2019
Come meet John F. Murray, Jr., who recently retired from FDA and joined SoftwareCPR®, at the course!
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