Design Controls — 21 CFR §820.30 in the U.S. and ISO 13485 §7.3 internationally — are the discipline by which medical-device manufacturers demonstrate that a design meets user needs and intended use, is verified against design input, validated in the use environment, and traceable in a defensible Design History File. Design Controls are one of the areas the FDA inspects most often, a frequent source of Warning Letters, and the operational core of the work of R&D engineers, quality engineers and regulatory professionals supporting 510(k) or PMA submissions.

This instructor-led online course builds operational competence in the FDA Design Control framework under 21 CFR §820.30 and ISO 13485:2016 §7.3. It covers every Design Control sub-clause — design and development planning, design input, design output, design review, verification, validation, transfer, changes and the Design History File. Students examine the integration of risk management (ISO 14971) with Design Controls, the role of human-factors engineering (IEC 62366-1) in validation, and the FDA QMSR Final Rule (effective 2026-02-02) integrating 21 CFR Part 820 with ISO 13485:2016. Case studies draw on publicly available Warning Letters citing specific §820.30 deficiencies.