ISO 13485 and the QMSR, design controls from design inputs through design outputs, verification vs. validation, the Design History File, document control, and CAPA.
ISO 13485:2016 — now incorporated directly into FDA's Quality Management System Regulation as of the February 2026 compliance date — is the quality system every device manufacturer runs its design and production process through, and this module builds the design controls process the standard requires: design inputs stated as unambiguous, verifiable requirements, design outputs traced bidirectionally back to those inputs, and the crucial distinction between design verification (did we build the device right, confirmed against specifications) and design validation (did we build the right device, confirmed against real user needs, typically through the human factors testing covered in Module 9).
It also covers the Design History File that reconstructs a device's entire development record for an FDA inspector, how document control keeps only current approved specifications in circulation, and the CAPA subsystem that investigates nonconformities and complaints down to root cause — a subsystem that feeds directly back into the risk management process in Module 3 whenever a field failure surfaces new information about a previously acceptable risk.