№ files_lp_4_process_1_29816
Year: 2026
Document Type: Standard Operating Procedure
Scope: Software as a Medical Device Development
Standards Referenced: IEC 62304:2006, ISO 14971:2019, IEC 62366-1:2015
Departments Involved: CEO, CTO, CPO, Software Engineers, Usability Engineers, Risk Managers, Subject Matter Experts
Process Steps: Design Input, Usability Engineering and Risk Management Planning, First Risk and Usability Assessment, Software Planning, Software Planning Review, Software Architecture, Detailed Design and Implementation
Outputs: Device Description, Vision Document, Software Requirements, Software System Test Plan, Risk Table, Risk Management Plan, Usability Evaluation Plan, Usage Scenarios, Software Safety Classification
Audience: Development teams in medical device software
Context: SOP document detailing procedures for developing medical device software integrating risk management and usability engineering, following IEC and ISO standards.
Price: 8 / 10 USD
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