Software Development Plan vs SaMD Procedure vs Software Bundle
Define which software you are documenting
Software that is itself a medical device and software used in production or quality-system activities have different documentation needs. Begin with intended purpose and use. Then distinguish a project roadmap, an organizational lifecycle procedure and the wider set of supporting evidence workflows.
Software Development Plan
The plan organizes phases, responsibilities, requirements, design, traceability, configuration, risk management and maintenance. Choose it when you need to organize lifecycle activities for a project and already have the governing processes. A project plan should reflect the actual development model, responsibilities and milestones rather than copy another project unchanged.
SaMD Development Procedure
The procedure governs the SaMD lifecycle from product planning and definition through requirements, design, implementation, verification, release and maintenance. It also addresses configuration control, deployment and decommissioning. Choose it when the repeatable development process is your gap. The separate plan can help translate that process into project-specific activities.
Five-document Software Procedure Bundle
The bundle includes SaMD Development, Software Validation, Human Factors and Usability Engineering, Software Clinical Evaluation, and the Software Development Plan. These documents address distinct needs. The Software Validation Procedure covers software and computer systems used in development, production and post-distribution quality activities; it is not a substitute for the SaMD lifecycle procedure.
A practical purchasing example
A SaMD team with established clinical-evidence and usability workflows but a weak development roadmap may review the plan alone. A team introducing SaMD development across the organization may need the governing procedure. A team missing several connected lifecycle and evidence workflows should compare the bundle and its exact inclusions.
Before you choose
Map the software’s intended purpose, existing procedures, project planning needs, use-related risks and clinical evidence responsibilities. Confirm which activities apply before adding documents to the QMS. The bundle supplies documentation, not software development services or completed validation evidence. Adapt responsibilities and interfaces, approve the documents and train the people who use them.
Compare the product scope
Document preview from Medical Device Software Procedure Bundle. Review the product page for the full list of included documents.
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