Software IN versus AS a Medical Device
The healthcare industry has always relied on new technology to drive it forward and improve the care that patients get. From the invention of things like the magnifying glass and the stethoscope centuries ago to complex machines like CT scanners and MRI invented just a few decades ago, technology is what allows medicine to evolve, adapt, and advance. Today is no exception. Technology is growing at a rapid pace, and doctors, researchers, scientists, and computer programmers are all working together to create new technology that revolutionizes healthcare. This technology allows the professionals who use it to save lives and to help people maintain better overall health.
Topics covered in this Whitepaper include:
- Software in a Medical Device (SiMD)
- Software as a Medical Device (SaMD)
- Overview of Key Differences
- SBOM Requirements for SaMD and SiMD
- Data Fields
- Automation Support
- Practices and Processes
