Software Development: What should your plan cover beyond coding?
Video transcript
What should a medical device software plan cover beyond coding? Start with the software’s scope, safety classification, life cycle, deliverables, and responsibilities. Plan verification and validation, configuration control, anomaly handling, and security activities. Define the evidence needed for release. Include supplier interfaces, maintenance, and what happens when support ends. These decisions belong in the plan, where the team can review them and keep them current as the project changes. Read AP Lyon’s Software Development Guide to see a selected planning excerpt and explore the full workflow.
Presented and narrated by Aaron Lyon, founder of AP Lyon. Published October 13, 2026.
Original planning excerpt: SOP 7-043 Rev 2, section 7.1.1, effective September 19, 2026.
Related document: Medical Device Software Development Plan. Review the included documents and examples to decide whether this procedure fits your work.