The Medical Software Development Life Cycle (MeSDLC) is a structured, regulatory-driven framework for designing, building, validating, and maintaining medical software in a safe and compliant manner.

It guides development from clearly defining the clinical problem and user needs through requirements engineering, system design, implementation, and rigorous verification to ensure the software is built correctly.
The lifecycle then progresses to validation and formal release, confirming the product fulfills its intended medical purpose in real-world settings.

Unlike traditional software lifecycles, MeSDLC emphasizes continuous risk management, traceability, and regulatory alignment at every stage.

Finally, it extends beyond deployment through post-market surveillance, ensuring ongoing monitoring, updates, and long-term patient safety throughout the product’s operational life.