Some of the requirements for the sanitary products that have incorporated computer programs, or for the computer programs that constitute products by themselves, such as the APPs, are:
- Programs will be developed and manufactured based on the current technical state, taking into account the life cycle principles of development, risk management, including information security, validation and verification, etc.
- La documentación del Expediente Técnico deberá incluir la verificación y validación del programa informático. Esta información contendrá normalmente un resumen de los resultados de verificaciones, validaciones y ensayos efectuados a nivel interno y en entorno de uso simulado o real antes de su aprobación final. / The documentation of the Technical File must include the verification and validation of the computer program. This information will normally contain a summary of the results of verifications, validations and tests carried out internally and in simulated or real use environment before its final approval.