Glossary

Software as a Medical Device (SaMD)

What is SaMD?

Software as a Medical Device (SaMD) refers to software that is intended to be used for one or more medical purposes and can perform these purposes without being part of a hardware medical device. SaMD can include software that diagnoses conditions, suggests treatments, or informs clinical management. It can run on general-purpose computing platforms and be interfaced with other medical devices, including hardware medical devices, and other software.

What are the key characteristics of SaMD?

  • SaMD is capable of running on general purpose (non-medical purpose) computing platforms like smartphones, tablets, or PCs
  • It may be used in combination with other products including medical devices
  • It may interface with other medical devices or other general-purpose hardware and software that provide input to SaMD

What is the difference between SaMD and hardware medical devices?

Software as a Medical Device (SaMD): SaMD is medical software that can run on general-purpose computing platforms, like smartphones, tablets, desktop computers, or cloud-based systems, without being part of a dedicated hardware device. It is designed for one or more specific medical purposes, such as diagnosing a condition, monitoring patient health, or analysing medical images. SaMD interacts directly with the user and can provide insights or recommendations based on the data it processes.

Hardware Medical Devices: Hardware medical devices, on the other hand, are physical devices or equipment used for medical purposes. Examples include X-ray machines, pacemakers, insulin pumps, and surgical instruments. These devices often have software components integrated into them, but the software cannot function independently of the hardware. The software is designed specifically for that hardware device and may control its functions, process data, or provide a user interface to interact with the device.

How does SaMD ensure regulatory compliance?

Ensuring regulatory compliance for Software as a Medical Device (SaMD) involves adhering to guidelines and standards set by regulatory bodies like the FDA. Properly classifying the SaMD is the first step, as it determines applicable regulations. Developers must then implement measures to meet regulatory standards, including design controls, risk management, and clinical evaluations. Thorough testing and validation ensure safety and effectiveness. Documentation is crucial, providing evidence of compliance and aiding in future audits. Staying informed about evolving regulations and standards, such as IEC 62304 and HIPAA, is also essential to maintain compliance.