Software Development and Maintenance Plan
Loading markdown content...
Ready to generate your document?
Talk to usNo commitments required
Use this Software Development and Maintenance Plan template to document and control all activities related to the development, maintenance, version control, verification, and validation of medical device software in compliance with IEC 62304 and ISO 13485. This template is essential for ensuring traceability, managing software changes, and meeting regulatory requirements throughout the software lifecycle, and should be completed at the start of software development and updated as the software evolves. It helps you organize responsibilities, document key deliverables, and ensure risk management—including SOUP evaluation—for each development stage.