Software as a Medical Device (SaMD) is defined by the International Medical Device Regulators Forum (IMDRF) as "software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device."
SaMD can be used on various cloud-based networks and manufacturers must understand and interpret regulations and guidelines that apply to them.
This webinar addressed critical SaMD regulations, guidelines, and implications for your quality management system (QMS) and helps you think through your approach for achieving a compliant IT development environment.
- What is and is not a regulated piece of SaMD
- What regulations must be addressed in the U.S. and Europe
- QMS considerations for SaMD
- Qualified IT environments and process automation for SaMD development
- Q&A
About the Presenters
Stepheni Norton, Director of Product Management, Digital and Cloud Solutions
Jay Crowley, Vice President of Medical Device Solutions and Services