SOP-SW-001 Software Lifecycle Procedure

Purpose

Define software lifecycle controls in line with IEC 62304 and ISO 13485.

Lifecycle Activities

• Development planning
• Requirements and architecture
• Detailed design and implementation
• Unit, integration, and system verification
• Release, maintenance, and problem resolution

Configuration and Change Control

• Every release has a unique version and release note.
• Approved change requests are required before implementation.
• Source control and CI artifacts are retained as quality records.

Cybersecurity and Data Integrity

• Apply secure coding controls and dependency checks.
• Document vulnerability review and mitigation outcomes.