Medical Device Software Procedure Bundle
Build a coordinated medical device software documentation set with five editable documents: SaMD Development, Software Validation for production and quality systems, Human Factors and Usability Engineering, Software Clinical Evaluation, and a Software Development Plan. Each addresses a distinct part of the lifecycle or its supporting evidence.
Supplied as five editable Microsoft Word documents in a digital download.
Medical Device Software Procedure Bundle - Contents
The bundle includes five editable documents:
Software as a Medical Device (SaMD) Development Procedure — Guides planning, realization and lifecycle control for a SaMD product.
Software Validation Procedure — Defines validation for computer systems and software used in medical device development, production and post-distribution quality activities.
Human Factors and Usability Engineering Procedure — Guides the assessment of users, use environments, critical tasks and use-related risks.
Software Clinical Evaluation Procedure — Guides assessment of clinical association, analytical validation and clinical validation evidence for SaMD.
Medical Device Software Development Plan — Organizes lifecycle phases, responsibilities, traceability, configuration, risk management and maintenance in a plan addressing IEC 62304:2006 including Amendment 1:2015, ISO/IEC/IEEE 12207:2026 and FDA guidance.
Software development and lifecycle controls
Software validation and revalidation
Clinical evaluation for software as a medical device
Individual documents in this bundle
Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.
Practical guide
Read Medical Device Software: Development, Validation and Clinical Evidence for workflow guidance, a checklist and common mistakes.
Software Development Plan vs SaMD Procedure vs Software Bundle
