Other terms
- Scabies
- SCC (Squamous Cell Carcinoma)
- Scleroderma
- SCORAD Assessment
- Screening Log
- Screening Process
- Sebaceous Gland
- Sebaceous Hyperplasia
- Seborrheic Dermatitis
- Sequencing
- Short Bowel Syndrome
- Skin Cancer
SaMDs (software as a medical device)
What is Software as a Medical Device? Software as a Medical Device (SaMD) is a category of technology used within medicine and 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."
Key features of SaMDs may encompass:
- Being able to perform diagnostics, monitoring, or treatment.
- The capability of running on general-purpose computing platforms.
- Integration with other software or medical devices.
Examples of SaMDs include:
- Software used to visualize images from diagnostic tests such as MRIs.
- AI-powered diagnostic tools used to analyze images, such as those from biopsies, to diagnose tumors or other pathologies.
- Mobile health applications used to track health data, including heart rate or the menstrual cycle.
What are the Benefits of Software as a Medical Device?
- Improved patient care through increased accuracy of diagnosis and personalization of treatment recommendations.
- Remote monitoring and management through access to real-time data, reducing the need for hospitalization.
- Increase accessibility to care.
Source: IMDRF SaMD Working Group. (2013). Software as a Medical Device (SaMD): Key Definitions. In International Medical Device Regulators Forum. The International Medical Device Regulators Forum. https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-131209-samd-key-definitions-140901.pdf
