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 run across various cloud-based networks, and manufacturers must understand and correctly interpret the regulations and guidelines that apply to them.
This on-demand webinar addresses critical SaMD regulations, guidelines, and their implications for your quality management system (QMS), and helps you think through your approach for achieving a compliant IT development environment.
What you'll learn
- What is, and is not, a regulated piece of SaMD
- Which regulations must be addressed in the U.S. and Europe
- QMS considerations specific to SaMD
- How qualified IT environments and process automation support compliant SaMD development
- Answers to common questions from the live Q&A
Why SaMD compliance starts with the development environment
Because SaMD performs a medical purpose without being part of a hardware device, the software itself — and the environment in which it is built and maintained — falls under regulatory scrutiny. Treating the development environment as in-scope from the start, rather than retrofitting controls later, makes it far easier to demonstrate control over the software lifecycle. A qualified IT environment paired with process automation reduces manual effort while producing the evidence needed to show a regulated SaMD product was developed under appropriate controls. For organizations operating on cloud platforms, sustaining that posture over time is the focus of USDM Cloud Assurance.
Navigating U.S. and European regulations
SaMD manufacturers frequently serve multiple markets, which means addressing more than one regulatory framework at once. Mapping your product against the applicable U.S. and European requirements early clarifies which controls your QMS must enforce and where your development environment needs qualification. Foundational practices such as electronic-records and signature controls under 21 CFR Part 11 compliance, together with a risk-based validation approach informed by Computer Software Assurance (CSA), give SaMD teams a defensible, efficient path to demonstrating compliance.
USDM's point of view: SaMD blurs the traditional line between "software" and "medical device," and that is exactly where compliance gaps appear. The teams that succeed treat regulation, the QMS, and the IT development environment as one connected problem — not three separate ones handed off between groups. Getting the qualified environment and process automation right up front turns compliance from a documentation scramble at the end into evidence that accumulates naturally as the software is built.
About the Presenters
Stepheni Norton, Director of Product Management, Digital and Cloud Solutions
Jay Crowley, Vice President of Medical Device Solutions and Services
Frequently asked questions about SaMD regulations and compliant development environments
What is Software as a Medical Device (SaMD)?
Per the IMDRF, SaMD is software intended to be used for one or more medical purposes that performs those purposes without being part of a hardware medical device. In practice, that means the software itself is the regulated product, and it can run across a range of cloud-based networks.
Is all medical software considered regulated SaMD?
No. Not every piece of software in a medical context qualifies as regulated SaMD. The webinar covers what is and is not a regulated piece of SaMD so manufacturers can correctly scope which products fall under SaMD regulations and which do not.
Which regulations apply to SaMD?
SaMD manufacturers typically need to address requirements in both the U.S. and Europe. The session walks through the regulations and guidelines that apply in each region and what they mean for your quality management system.
How does SaMD affect my quality management system (QMS)?
SaMD introduces specific QMS considerations that the webinar addresses directly, including how to align your QMS with the applicable regulations and how a qualified, controlled IT development environment supports compliance.
What makes an IT development environment compliant for SaMD?
A compliant approach centers on qualified IT environments and process automation for SaMD development. The webinar helps you think through how to achieve a compliant development environment that produces the evidence and controls regulators expect.
Watch the on-demand webinar. Hear Stepheni Norton and Jay Crowley walk through SaMD regulations, QMS considerations, and how to build a compliant development environment. Have questions about your specific SaMD product or development environment? Contact USDM to talk with our medical device and cloud compliance experts.