United States · Certification
ISO 13485 certification in the United States
Achieve ISO 13485 certification in the US with Sterling: 8,100+ client engagements in 60+ countries, 20+ years.
- Accredited certification
- New York office team
- Effivity software included
- Academy training included
Who asks for ISO 13485 in the US
Clients include
ISO 13485 certification in the US at a glance
FDA Quality Management System Regulation (21 CFR Part 820) requires ISO 13485 for the organisations it covers. Most US buyers ask for it anyway.
Since 2 February 2026, the FDA's device good manufacturing practice rule has carried a new name and a new foundation: the Quality Management System Regulation, 21 CFR Part 820, incorporates ISO 13485:2016 by reference. For finished device manufacturers intending to distribute in the US, the international standard is now the core of the domestic requirement, and FDA inspects against it under its updated compliance programme. FDA checks conformity through inspection; an accredited ISO 13485 certificate, issued by a certification body after stage 1 and stage 2 audits, is a separate step that export markets, distributors and many OEM customers ask for. Device makers, contract manufacturers, sterilisation and component suppliers, and software-as-a-medical-device developers therefore often pursue both. Sterling builds one system that serves the two, covering design controls, risk management, supplier controls, complaint handling and CAPA, with Effivity and Sterling Academy included. The local route and questions follow.
Who needs ISO 13485 in the US, and what happens without it
For some organisations in the US it is a legal requirement. For most, the question comes from a buyer, a regulator or a partner that wants proof before it signs. These are the organisations that get asked.
- Finished medical device manufacturers distributing in the USQMSR incorporates ISO 13485:2016 by reference.
- Manufacturers of device accessoriesFDA treats accessories as finished devices subject to the QMSR.
- Contract manufacturers and component suppliersDevice makers flow down quality requirements and often ask for certification.
- US device makers exporting abroadExport markets ask for an accredited ISO 13485 certificate.
Not sure which of these applies to you?Answer a short set of questions and your readiness report arrives by e-mail.
Take the ISO 13485 readiness checkISO 13485 requirements in the US
Strip away the vocabulary and ISO 13485 requires a company to prove six things about making medical devices that are safe and work as intended.
In the US these six sit alongside the local laws and regulations listed under drivers below; one system can evidence both. The detail is on the global hub: ISO 13485 explained →
How to get ISO 13485 certified in the US
One team from the New York office carries the work from scoping to certificate. Delivered from the New York office across the US, with remote delivery for teams in other time zones and on-site work as agreed.
- Discovery call and scopeEntities, locations, regulators and target date, agreed before any proposal.
- Gap assessment against ISO 13485 and the US requirements that apply to youControls you already run for your regulators and customers are reused, not rebuilt.
- Your system built with your team in EffivityRisks, controls, evidence, incidents and reviews in one live system the auditor can see.
- Internal audit, management review and corrective actionsYour internal auditors trained by Sterling; the evidence proven before the certification body arrives.
- Certification body stage 1 and stage 2, then surveillanceAn accredited body audits and decides. Sterling supports the audits and the three-year cycle.
- End to end, from one team
- Effivity ISO & GRC software
- Preferential Sterling Academy access, with complimentary awareness training for your people
- Internal auditor training for your audit team, as applicable to your standard
- Vulnerability assessment on ISMS engagements
The Sterling Promise: 100% on-time completion, 100% success, 8,100+ client engagements.Sterling does not certify. Certification decisions stay with independent bodies.
How long does ISO 13485 certification take in the US?
There is no standard duration: it depends on your scope and on how much of the system already runs. In the US these are the factors that set the timeline.
- Device classes and design activities in scope
- Existing QSR-era procedures to transition to the QMSR
- Supplier controls and complaint handling evidence
- Certification body availability
Sterling agrees a dated plan with you on the discovery call, once the scope is known.
How much does ISO 13485 certification cost in the US?
The cost has two parts: the consulting work to build and prove the system, and the certification body’s audit fees, which are quoted separately. In the US these factors move both.
- Number of sites, products and outsourced processes
- Design control and risk management documentation
- Certification body audit fees quoted separately from consulting
- Integration with FDA inspection readiness
Sterling gives one customised, all-inclusive proposal after the discovery call, never before the scope is agreed.
ISO 13485 consultants and certification bodies in the US
Two different organisations are involved. A consultant helps you build the system and prove it works; an accredited certification body then audits or assesses it and decides. Keeping the two separate is what makes the result credible to buyers and regulators.
- Check that the body’s accreditation or approval covers ISO 13485 and your sector, and that its certificates can be verified online.
- Ask the consultant how the local requirements in the US are mapped into the same system, so nothing runs twice.
- Ask for client references in your sector; Sterling’s client letters are available on request.
- Agree who owns the evidence and the tool after the engagement; with Sterling the system stays yours, in Effivity.
Laws and regulations that drive ISO 13485 in the US (2)
| Instrument | How it treats the standard |
|---|---|
| FDA Quality Management System Regulation (21 CFR Part 820) | Requires Incorporates ISO 13485:2016 by reference, effective February 2, 2026. |
| IAS accreditation of management systems certification bodies | Market driver Accredited certification for management-system standards is available through a US accreditation body; no mandate. |
Accreditation, audit language and remote audits in the US
Use a certification body accredited for this standard by an accreditation body within the international mutual recognition arrangements (Global ACI — Global Accreditation Cooperation Incorporated, formerly the IAF MLA), US-based (for example IAS, which accredits management systems certification bodies) or foreign; check that the accreditation scope covers the standard and your sector. No body is named here unless its accreditation scope has been verified. Edition and transition details: ISO 13485 hub →
Audit language
Audits are conducted in English; agree the audit and document language with the certification body at application.
Remote and on-site
Remote audit elements are at the certification body's discretion under its accreditation rules; operational sites are normally visited on-site.
ISO 13485 in the US: questions clients ask
Does the FDA require ISO 13485?
Not as a certificate, but the standard still binds finished device makers. The FDA's Quality Management System Regulation, 21 CFR Part 820, incorporates ISO 13485:2016 by reference. Whether you also need an ISO 13485 certificate depends on your customers and export markets. Confirm the regulatory position with your regulatory adviser.
Is FDA conformity the same as ISO 13485 certification?
No. The FDA checks conformity through inspection, while an ISO 13485 certificate is issued by an accredited certification body after its own audit. They are two separate routes with different decision-makers, and one does not replace the other. Plan for FDA inspection regardless of any certificate you hold.
When did the QMSR take effect?
The Quality Management System Regulation took effect on 2 February 2026. It sits at 21 CFR Part 820 and incorporates ISO 13485:2016 by reference. Check the FDA's page for the current requirements, and ask your regulatory adviser how your procedures line up with them.
More on ISO 13485 for US organisations
Other standards US businesses ask Sterling for
Organisations in the US often combine ISO 13485 with one of these, under one management system where the scopes allow.
Start with a free discovery call from the New York office
A Sterling consultant goes through your entities, your regulators and your target date with you. No proposal until the scope is agreed.
Sources
- FDA Quality Management System Regulation (21 CFR Part 820) — fda.gov (accessed 5 Oct 2026)
- IAS accreditation of management systems certification bodies — iasonline.org (accessed 5 Oct 2026)
- International Accreditation Service (IAS) — iasonline.org; iaf.nu (accessed 5 Oct 2026)
Talk to a consultant
Plan your certification with the New York team.
Tell us your goals, locations and target date. We’ll help you define the scope, timeline and next steps.
usa@sterling-grc.com+1 201 263 4443 (global headquarters) · your nearest office and its number are at the top of this page
What would you like to achieve?
Choose a starting point. The enquiry form takes about a minute.
Book my free discovery callContinue to the enquiry form to share your details. Please do not include passwords, sensitive personal information or confidential files. A Sterling consultant replies within one working day. Privacy notice