last highlighted date: 2024-02-26
Highlights
- Medical device software generally falls into two categories: software that functions as a medical device (SaMD) or software that is integrated into one (SiMD). In either case, it must comply with the high standards accompanying its development lifecycle and account for the collection of design history files, requirements traceability, and risk and threat modeling. That’s where specialized standards like IEC 62304 come into play.
- In most other software development cases, we view risk in terms of organizational vulnerability and financial loss. However, the FDA puts the potential risk to a patient’s health front and center when considering the interaction with SaMDs and SiMDs.