IMDRF N88 Good Machine Learning Practice for Medical Device Development: Guiding Principles (2025) P2: Apply good software engineering, device design and security practice throughout

What does P2 require?

Model design is implemented and maintained on sound fundamentals: robust software engineering, usability, assurance of data quality, management of data, cybersecurity and quality management, with methodical risk management and design processes that record and communicate decisions and their rationale and secure traceability, reproducibility and the authenticity, confidentiality, integrity and availability of data. The infrastructure for deploying, monitoring and maintaining the model is thought through, and patient data is used ethically in support of patients' rights, safety and welfare.