Non-clinical bench testing is the objective evidence that demonstrates a medical device meets its design inputs before it reaches the patient. The bench-testing protocols supporting any 510(k), De Novo, or PMA submission require command of the chain that runs from risk analysis (ISO 14971) through test selection (IEC 60601-1 for electrical safety, IEC 62366-1 for usability, the IEC 60601-2-XX collateral standards by modality, the applicable ASTM standards) to statistical planning (sample size, quantitative acceptance criteria) and defensible evidence generation. The FDA has consolidated the Safety and Performance Based Pathway as an alternative to the conventional 510(k) based precisely on demonstration of conformance to objective safety and performance criteria.

This 16-hour Curso de Certificación Profesional is the entry point of the Aleph Ensayos de Seguridad y Desempeño del Producto course track. It introduces the vocabulary of non-clinical bench testing; the FDA Safety and Performance Based Pathway at orientation depth; IEC 60601-1 basic safety and essential performance terminology; and the connections between bench testing, ISO 14971 risk management, and IEC 62366-1 usability engineering. The course also orients participants to benefit-risk reasoning — the integration of clinical benefit with residual-risk profile and population-level safety considerations — that supports modern regulatory decision-making.

The course prepares participants for the Avanzado level (`RAQ-532-A`), where the same content is exercised at applied depth — applied FMEA and FTA on a chosen device, applied ISO 14971 process work, applied IEC 60601-1 testing planning, applied IEC 62366-1 integration, applied post-market analysis using MAUDE and EU MDR PSUR, and an authored Risk Management File plus Risk Management Report plus benefit-risk analysis. Together the Introductorio and Avanzado levels form a 48-hour course track.

The Introductorio course establishes the safety / performance vocabulary the medical-device and IVD industries expect of someone entering Design Assurance, Quality, or Asuntos Regulatorios roles with bench-testing responsibility. Employers in this space include medical-device manufacturers, IVD manufacturers, test laboratories, and consultancies serving manufacturers.

Los participantes que cumplan los requisitos de finalización del curso reciben un Certificado de Finalización emitido por Aleph University.