The seven-phase delivery process produces a defined set of compliance outcomes. On completion, the organisation holds a signed Declaration of Conformity, a CE-marked system, a registration entry in the EU database, and a complete AISDP with all twelve modules populated and traceable to source evidence.

The AISDP becomes a living document. Each material change to the system, its documentation, or its operational context creates a new version. The version history demonstrates the organisation’s continuous compliance discipline throughout the system’s operational lifetime and during the ten-year post-market retention period.

The thirteen domains addressed in this documentation (risk assessment, model selection, data governance, development architectures, version control, CI/CD pipelines, cybersecurity, conformity assessment, certification, regulator interaction, post-market monitoring, operational oversight, and technical delivery) are deeply interdependent. A deficiency in one propagates through others, often surfacing as a compliance failure far from the original gap. The strategic synthesis in maps these dependencies and provides a maturity model, common pitfalls, and a readiness assessment framework to help organisations evaluate their compliance posture holistically.

Key outputs

• Complete AISDP (twelve modules)
• Signed Declaration of Conformity
• CE marking evidence
• EU database registration confirmation
• Post-market monitoring plan (operational)