The FDA’s Software Engineering Laboratory has performed or been involved in a number of activities related to infusion pump safety, model based development and static analysis. The link provided is to FDA’s primarary web page on these activities.
ISO13485:2015 ISO 13485 Internal Audit(or) Training Course (Live, 3-day)
IEC 62304 and other Emerging Standards Impacting Medical Device Software (Live, 3-day)
Being Agile & Yet CompliantISO 14971 SaMD Risk Management
Software Risk Management
Medical Device Cybersecurity
Software Verification
IEC 62366 Usability Process and Documentation
Or just email training@softwarecpr.com for more info.
