All terms
Software in a Medical Device
Software embedded in or required to operate a hardware medical device.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
Software in a Medical Device (SiMD) refers to software that is embedded within, or required for, the operation of a hardware medical device - such as firmware controlling an infusion pump or imaging system. What the regulation says
Software in a Medical Device (SiMD) is considered a component of a hardware medical device and is regulated as such, rather than as a standalone medical device. The FDA addresses this in its guidance on "Software as a Medical Device (SaMD): Clinical Evaluation," clarifying that SiMD falls under the regulatory framework of the device it enables. Similarly, under the EU Medical Device Regulation (EU MDR) 2017/745, SiMD is subject to the general safety and performance requirements (GSPRs) applicable to the overall medical device, as outlined in Annex I.What this means in practice
Unlike SaMD, SiMD is regulated as part of the parent device. It is still subject to IEC 62304, cybersecurity requirements, and design controls.Examples
- Firmware that controls the delivery mechanism and dosage calculations of an insulin pump is an example of SiMD.
- Software embedded in an MRI machine that processes imaging data and controls the scanner's operations is considered SiMD.
- The operating system and user interface software on a patient monitor that displays vital signs is an instance of SiMD.
Common pitfalls
- •Failing to integrate SiMD development and maintenance into the overall medical device's lifecycle management processes can lead to regulatory non-compliance.
- •Overlooking the specific cybersecurity risks associated with integrated software can compromise the safety and effectiveness of the medical device.
- •Treating SiMD with less rigor than standalone software regarding design controls and validation activities is a common mistake.
- •Assuming that general software development practices are sufficient without adapting them to medical device regulations is a pitfall.
- •Neglecting to update SiMD in response to new cybersecurity threats or operating system changes can lead to vulnerabilities and regulatory issues.
Frequently asked questions
SiMD is integral to the functioning of a hardware medical device and is regulated as part of that device. SaMD, in contrast, is software that itself constitutes a medical device and performs a medical function without being part of a hardware medical device.
Cross-references
Governed by
Related terms
Shared paths + categorySoftware & AI
Software as a Medical Device(SaMD)
Software intended for medical purposes that performs without being part of a hardware device.
SaMD & AI/ML Devices · adjacentSoftware Team Onboarding · adjacent
Standards
IEC 62304
Lifecycle requirements for medical device software.
SaMD & AI/ML Devices · adjacentSoftware Team Onboarding · adjacent
Software & AI
Clinical Decision Support(CDS)
Software providing healthcare professionals with knowledge and patient-specific information.
SaMD & AI/ML DevicesSoftware Team Onboarding
Software & AI
Predetermined Change Control Plan(PCCP)
FDA mechanism to pre-authorize specific modifications to AI/ML-enabled devices.
SaMD & AI/ML DevicesSoftware Team Onboarding
Software & AI
Software of Unknown Provenance(SOUP)
Software not developed for medical device use, or lacking adequate development records, incorporated into a device.
SaMD & AI/ML DevicesSoftware Team Onboarding
Software & AI
Software Safety Classification
IEC 62304 classes A, B, C reflecting potential harm from software failure.
SaMD & AI/ML DevicesSoftware Team Onboarding
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Primary references
3 sourcesLink health: 3 verified· last checked 2026-06-20
FDA·2IMDRF·1
- 1FDA Software FunctionsVerifiedFDAfda.gov
- 2FDA - AI/ML-Enabled Medical DevicesVerifiedFDAfda.gov
- 3IMDRF - Software as a Medical DeviceVerifiedIMDRFimdrf.org
Inline markers like [1] jump to the matching reference above.