Controles de Diseño are the disciplined framework by which medical-device manufacturers translate a defined clinical need into a verified, validated, transferable product. The FDA codifies the framework in 21 CFR §820.30 — soon governed by the QMSR (effective February 2, 2026, with ISO 13485:2016 incorporated by reference). The framework is structured around ten sub-clauses (a)–(j) covering scope, planning, inputs, outputs, review, verification, validation, transfer, changes, and the Design History File. Controles de Diseño failures appear repeatedly in FDA Warning Letters and in the root-cause analysis of recalled devices.

This 16-hour Curso de Certificación Profesional is the entry point of the Aleph Controles de Diseño course track. It introduces the 21 CFR §820.30 framework; the ten sub-clauses at orientation depth; the canonical distinction between Design Verification (§820.30(f), “did we build the product right?”) and Design Validation (§820.30(g), “did we build the right product?”); the role of Design Review (§820.30(e)) as cross-functional governance; the Design History File (§820.30(j)) as the auditable record of the design effort; and the alignment with ISO 13485:2016 §7.3 Design and Development.

The course prepares participants for the Avanzado level (`RAQ-610-A`), where the same content is exercised at applied depth — applied Design Input authoring, applied Design Output mapping, applied Design Review governance, applied V&V planning, applied Design Transfer planning, applied Design Change handling, and an authored Design History File for a chosen device. Together the Introductorio and Avanzado levels form a 48-hour course track.

The Introductorio course establishes the Controles de Diseño vocabulary the medical-device industry expects of any professional with a stake in design-program compliance. Employers in this space include medical-device manufacturers, IVD manufacturers, and consultancies serving manufacturers.

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