ISO 13485:2016 sets the quality management requirements for organizations involved in the lifecycle of medical devices, from design through service. It is widely used to show conformity under EU MDR and IVDR, anchors the MDSAP audit model for multi-country acceptance MDSAP, and, as of 2 February 2026, is incorporated into FDA’s new Quality Management System Regulation FDA QMSR. The standard emphasizes risk-based controls, validation of production and QMS software, supplier oversight, and robust postmarket feedback and complaint handling. Organizations use it to align processes, documentation, and records with regulatory expectations while enabling consistent product realization and continual improvement across sites and partners.

Where this term comes up

Medical Devices

How V5 handles it

Score your compliance gap — then download the validation pack.

A guided self-assessment walks you against the regulator clauses that apply to your industry. The validation pack — IQ/OQ scripts, traceability matrix, risk assessment, intended-use statement — generates from the same evidence so you can hand it to an auditor on day one.

Document control — one version in force, every change signed and explained.

Draft the next revision while the current one stays in use, approve it under your sign-off route, and track training on it — with the history kept.

QMS — quality records next to the work they concern.

Deviations, corrective actions and quality review sit in the same system as production, so each quality record references the work order, step and lot it concerns.

ISO 13485

Next step

ISO 13485

Next step