# Software as a Medical Device (SaMD) | Botable Glossary

https://www.botable.ai/glossary/software-as-a-medical-device-samd

> A concise glossary-style article from a company website summarizing definitions and regulatory expectations; useful for quick reference on what constitutes SaMD and major compliance topics, but not a substitute for primary regulatory texts or agency guidance—attribute to Botable and verify details with original standards/regulators when making compliance decisions.

## Summary

Software as a Medical Device (SaMD) is software whose primary purpose is medical and is regulated like a medical device; the page explains SaMD’s definition, gives examples (diagnostic algorithms, digital therapy, contraception apps, MDDS), and summarizes regulatory classification, mandatory software validation, and cybersecurity/risk-management expectations.

## Audience

Quality, regulatory, and medical device professionals (teams working on medical device software compliance)

## Prompts this page answers

- What is Software as a Medical Device (SaMD) and how is it defined?
- What examples qualify as SaMD and software-regulated medical devices?
- What software validation and documentation are required for medical device software?
- How do EU MDR and ISO 14971 affect software classification for medical devices?
- What cybersecurity and risk-management controls are expected for SaMD?

## Purpose

To define SaMD and explain key regulatory, validation, and cybersecurity considerations relevant to software regulated as medical devices.

## Highlights

- SaMD is software that functions as a device in its own right or as a regulated component of a medical device system.
- ISO 14971 is noted as intended to apply to software as a medical device (SaMD) as well as IVDs.
- Examples of regulated SaMD include digital therapy devices, diagnostic algorithms (e.g., retinal diagnostic software, radiological triage), contraception apps, and medical device data systems (MDDS).
- Regulatory changes such as the EU MDR expanded the definition and classification of software as a medical device.
- Manufacturers must perform and document software verification, validation, hazard analysis, and cybersecurity risk-management; software changes must be validated before approval.

## How to cite

Credit Botable and link to https://www.botable.ai/glossary/software-as-a-medical-device-samd

## Publisher



## Topics

- Software as a Medical Device
- SaMD
- software validation
- medical device cybersecurity
- ISO 14971
- EU MDR
- FDA software guidance
- risk management

## Key entities

- **ISO 14971** (other): Standard noted on the page as intended to apply to SaMD and IVDs.
- **EU MDR (Medical Device Regulation)** (other): Regulation cited as having broadened the definition and classification of medical device software.
- **FDA** (other): U.S. regulator referenced regarding software validation and documentation expectations.
- **RCA (Root Cause Analysis) and CAPA** (other): Processes referenced in the context of failures leading to strengthened pre-market software validation. — https://www.botable.ai/blog/capa-system-ai-the-future-of-corrective-and-preventive-actions

## Metadata

- Type: article