Review Medical Device software design history file documents for Good Documentation Practices (ALCOA+), Compliance to 21 CFR 820, ISO 13485:2016, ISO 14971:2019, and IEC 62304. Also reviewed for suitability for FDA 510k and EU CE Mark / EU MDR submissions. Software plans, software requirements, software risk assessments, software architectural design, software test plans and protocols, software test reports, traceability matrices, risk management reports, validation summary reports, change records.