Review organizational procedures for Medical Device software life cycles, planning, design inputs, design implementation, design outputs, design verification, design validation, design change, and design history files. Verify compliance to applicable regulatory requirements including 21 CFR 820, ISO 13485:2016, ISO 14971:2019, and IEC 62304. Coverage for various life cycle models including waterfall, iterative waterfall, and Agile. Includes both Software In a Medical Device (SiMD) and Software As a Medical Device (SaMD).