Medical Device Software Development Plan

$119.00

Supplied as an editable Microsoft Word document as a digital download.

Software lifecycle activities and responsibilities

Organize medical device software lifecycle activities with this editable Software Development Plan document. It guides phases and responsibilities, requirements, design, traceability, configuration and risk management, and maintenance while addressing IEC 62304:2006 including Amendment 1:2015 and related software lifecycle guidance.

The Software Development Plan addresses content contained within IEC 62304:2006 including Amendment 1:2015, ISO/IEC/IEEE 12207:2026 and FDA Guidance. The Medical Device Software Development Plan helps the user to organize the necessary roadmap, phases and tasks required throughout the development lifecycle, regardless of which life cycle model or approach is employed.

Software definition, requirements and design specification
Development phases, roles and traceability
Configuration management, risk management and software maintenance

Standards and frameworks addressed: IEC 62304:2006 including Amendment 1:2015; ISO 13485:2016; FDA QMSR.

Instructive Document

For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.

For the wider SaMD development process, see the SaMD Development Procedure. For clinical evidence supporting software claims, see the Software Clinical Evaluation Procedure.

Practical guide

Read Medical Device Software: Development, Validation and Clinical Evidence for workflow guidance, a checklist and common mistakes.

Part of a procedure bundle

This document is also included in Medical Device Software Procedure Bundle. Explore the bundle for the related documents.

Software Development Plan vs SaMD Procedure vs Software Bundle