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ISO 9001:2026 published · transition until 30 Sep 2029

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ISO 13485Medical devices

It requires a quality management system for medical devices, with regulatory requirements, risk management and traceability.

ISO 13485:2016Certification under accreditation
Start ISO 13485 certificationRequest a proposal How the process worksProcess
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What it demonstrates

  1. It requires a quality management system for medical devices, with regulatory requirements, risk management and traceability.
  2. The audit checks those controls across the product life cycle.
Sectors
  • Medical device manufacturers
  • Importers and distributors
  • Technical services
Edition
ISO 13485:2016
Discipline
Sector-specific
Topic
Food and health
Public status
Third-party certification · published accredited scope

Accredited scope published in the Trust Center · 30-06-2026

Why now

The FDA QMSR has applied since 2 February 2026 and incorporates ISO 13485:2016 by reference. For anyone selling to the United States, 13485 is no longer optional.

ISO 13485, step by step

Initial certification follows these steps.

See how the process works
  1. Enquiry and scope

    What you are asked for, what activities you carry out, and at which sites and in which country you operate.

  2. Proposal

    In writing, sized to the standard, the activities, the sites and the country.

  3. Audit

    The assigned team assesses the documentation and the operation with evidence.

  4. Verifiable certificate

    A function separate from the audit team decides. The certificate can be checked by its code.

  5. Continuity

    Continuity of the cycle is agreed for your case.

Who audits
The audit team assigned to the case, with declared competence for the standard.
Who decides
A function separate from the audit, in accordance with ISO/IEC 17021-1.
Who issues
G-CERTI Co., Ltd.
Where it is checked
The public certificate register, by code. Verify

Issuance depends on the audit and an independent decision.

FAQ

How much does certification cost?

There is no list price: the proposal is sized on standard, scope, sites, headcount, activities, system complexity and delivery mode. The request is reviewed first and the proposal is then issued.

What happens if the audit raises findings?

Findings are documented and classified. The organization submits correction, root cause and corrective action with evidence; the audit team evaluates it and only then does the file go to decision.

Who decides on certification?

A competent function separate from the audit team. Those who audit do not decide, and no outcome is anticipated before that review.

Where can an issued certificate be checked?

In the public certificate register, by code.

Verify a certificate

Other standards on the same topic

See the full catalogue
An organization's team with its certificates
Certificate deliveryG-CERTI archive

Request your ISO 13485 proposal

The proposal arrives in writing, with the standard, the scope and the timeline.

Start ISO 13485 certificationRequest a proposal Verify certificateVerify