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.

QUALIPHARMA MEDICAL DEVICES puts at the service of our clients, expert professionals for the Verification and Validation of Softwares as a Health Products in agreement – UNE EN 62304 – Medical device software. Software Cycle Processes