Design Controls 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. Design Controls failures appear repeatedly in FDA Warning Letters and in the root-cause analysis of recalled devices.

This 16-hour Professional Certificate Course is the entry point of the Aleph Design Controls 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 Advanced 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 Introductory and Advanced levels form a 48-hour course track.

The Introductory course establishes the Design Controls 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.

Participants who meet the course completion requirements receive a Certificate of Completion issued by Aleph University.