Problem Definition

This phase clearly defines the clinical or medical problem the software intends to solve and identifies the target users. It establishes the intended medical purpose and determines the appropriate regulatory classification. Additionally, it outlines the project scope, constraints, and potential risks to ensure a focused and compliant development pathway.

Requirments

This phase gathers stakeholder needs and translates them into structured, testable requirements. It defines both functional requirements (what the system must do) and non-functional requirements (such as performance, security, and usability). Risk analysis and traceability mechanisms are incorporated to ensure safety, regulatory compliance, and alignment with the original problem definition.

Design & Modeling

This phase develops the overall system architecture and detailed technical design specifications. It models workflows, data flow, and system interactions to ensure clarity before development begins. Safety-by-design principles and cybersecurity controls are integrated to reduce risks early in the lifecycle.

Implement & Validate

This phase involves coding the system according to the approved design specifications. The software is tested through unit testing, integration testing, and static and dynamic analysis to confirm it meets defined requirements. Verification ensures the product is built correctly and functions as intended at a technical level.

Validate & Release

This phase confirms that the software fulfills its intended medical purpose in real-world or simulated clinical environments. Clinical and usability validation ensure the system performs safely and effectively for end users. Regulatory documentation is finalized, and the product is formally released to the market.

Lifecycle monitoring

This phase monitors the software’s performance after release in real-world settings. It includes adverse event reporting, complaint management, and continuous risk evaluation. Updates, patches, and improvements are implemented to maintain safety, compliance, and long-term effectiveness.