About this document
Understanding Software as a Medical Device by AptSkill is a document available to read on EtoBox.
Software as a Medical Device (SaMD) refers to software intended for medical purposes that operates independently of hardware medical devices. SaMD is distinct from software that drives or is embedded in medical devices and can include mobile apps and modules interfacing with other products. Regulatory considerations for SaMD vary by region, with specific classifications based on the potential impact on patient health outlined by the FDA and EU MDR guidelines.
- Author
- AptSkill
- Language
- EN