ISO 13485 · Medical devicesISO certification

ISO 13485: the quality the regulator expects.

ISO 13485 is the quality management system for those who work across the life cycle of medical devices. In Europe it is the harmonised standard that gives presumption of conformity with the MDR Regulation; in the United States, the FDA has referenced it since 2 February 2026.

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What it is

A quality system written for the rules, not just for the customer.

The standard sets quality system requirements specific to medical devices and geared to regulatory compliance: risk management, traceability, process validation. It does not follow the common structure of the other ISO standards: it integrates with ISO 9001 through a correspondence table.

Who needs it

Medical device manufacturers under Regulation (EU) 2017/745
Suppliers of components, materials and services to manufacturers
Companies developing software that is a medical device
Companies exporting devices to the United States

What it brings you

The MDR Regulation requires manufacturers to have a quality system; applying the harmonised EN ISO 13485 gives presumption of conformity for the requirements it covers.
Reg. (UE) 2017/745, art. 10(9) and art. 8(1)
Since 2 February 2026, the FDA’s QMSR has incorporated ISO 13485:2016 by reference. The certificate, however, does not replace FDA inspections.
FDA, Quality Management System Regulation
In Italian tenders that provide for it, the guarantee is reduced by up to 20%: UNI CEI EN ISO 13485:2016 is among the certifications in Annex II.13.
D.Lgs. 36/2023, art. 106 c. 8 and allegato II.13

The path

From analysis to certificate, and to CE marking.

1
Gap analysis
What the standard and the MDR require, compared with what the company does: design, production, suppliers, post-market.
2
The system, written and lived
Procedures, records and technical documentation, with risk management across the whole life cycle of the device.
3
Internal audit and review
Before the certification body, an internal audit and the management review show whether the system holds up.
4
The body’s audit
For CE marking under the MDR, the quality system is assessed by a notified body, with audits at least every 12 months; its certificates last 5 years at most.

10ISO

How 10ISO will help you

The agents will do the work that repeats itself; decisions stay with you and whoever supports you. 10ISO is coming soon: this is what we’re building.

What’s missing, requirement by requirement, with the MDR article next to itComing soon
Documents and records under control: versions, approvals, traceabilityComing soon
Suppliers and complaints followed through to corrective actionComing soon
The correspondence with ISO 9001, for those who keep bothComing soon

Read alongside

Questions

The first questions people ask about ISO 13485.

Is ISO 13485 mandatory for the MDR?

The MDR requires a quality system, not a specific standard. Applying the harmonised EN ISO 13485, however, gives presumption of conformity for the requirements it covers.

Can I integrate it with ISO 9001?

Yes, with a mapping: 13485 adds regulatory requirements and does not share the common structure of the other ISO standards, so integration goes through a correspondence table.

Do I need it to sell in the United States?

Since 2 February 2026, the FDA has incorporated ISO 13485:2016 into its QMSR. The certificate, however, does not replace FDA inspections.

Sources

Every reference on this fact sheet comes from one of these sources, checked on 28/09/2026. If a law or a standard changes, the fact sheet is updated.

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