Medical-device development is unlike typical software or manufacturing environments because products directly impact patient safety and must satisfy stringent regulatory expectations across the entire product lifecycle. The U.S. FDA’s Quality Management System Regulation (QMSR), which becomes enforceable February 2, 2026, replaces the former Quality System Regulation (QSR) and aligns 21 CFR Part 820 with ISO 13485:2016 principles. This harmonization elevates global consistency while preserving core quality expectations.