Get an international ISO 13485 certificate for medical device manufacturers and distributors

ISO 13485:2016 is the international standard for quality management systems for medical devices. GOST ISO 13485-2017 is its interstate version with the same requirements. In Belarus it is in force as a state standard, and it is also used for certification in Russia.

What differs is the certification body and where the certificate is recognized. For work within the country, a certificate from a body accredited by the Belarusian State Centre for Accreditation is often enough. For export, choose ISO 13485 from an internationally accredited body; for medical device registration and tenders, the right option depends on the requirements of the regulator or the customer.

We check the requirements of your customer or the tender documentation and recommend only the certificates they actually list.

The certificate is issued by an independent certification body. It makes the decision based on its own audit.

We prepare your quality management system (QMS) and documents, select a certification body for your goals and support your company through the certification audit.

The certificate itself is not mandatory, but it makes registration easier. Under EAEU rules and for national registration in Belarus, an ISO 13485 or GOST ISO 13485-2017 certificate is attached to the dossier if you have one.

For class 2a (sterile), 2b and 3 devices, EAEU rules make the QMS itself mandatory: it is checked during the inspection of production, and a valid certificate reduces the scope of this inspection. For class 1 and non-sterile class 2a devices, a QMS is voluntary.

The certificate does not replace registration: a registration certificate also requires a technical file, risk management under ISO 14971 and test data for the device class.

We prepare you for certification and arrange an apostille for the submission as a separate service. You or your regulatory specialist submit the registration dossier.

The set of documents depends on the device class, the size of your organization, the number of sites and how your processes already work.

Typically you need:

• a quality policy and quality objectives;
• a description of the QMS scope;
• risk management under ISO 14971;
• design and production, process validation;
• traceability and supplier management;
• post-market surveillance;
• control of documents and nonconformities.

We develop or adapt the documentation for your company, train the responsible employees and prepare your organization for the certification audit.

Certification usually takes 30 to 75 business days; when the system is built from scratch, expect the upper end. The timeline depends on the device class, your headcount, the number of sites, how ready your documentation is and the auditors’ schedule.

First we assess the current state of your QMS, then we prepare the documents, train the responsible employees, conduct an internal audit, and support your company during the certification audit and while nonconformities are corrected. We fix the exact timeline and stages before the project starts.

International ISO 13485 certification for a company with up to 25 employees starts at $2,250, including preparation and the certification audit. The final cost depends on the device class, your headcount, the number of sites, the certification scope, the chosen certification body, and whether you need a national certificate under GOST ISO 13485-2017 or an international ISO 13485 one.

The calculator on this page shows an approximate price in Belarusian rubles and US dollars. After a call to clarify your goals, we send you a quote with the exact price and fix it in the contract. Payment in installments: 50/50 or 25/50/25, with the final payment after you receive the certificate.

For export, we choose a certification body whose accreditation is part of the international mutual recognition system Global ACI MRA (formerly IAF MLA). A foreign partner or distributor will find such a certificate easier to accept. Within the country, including for tenders, a certificate without international accreditation is often enough, so we choose the option to fit your goals and budget.

But there is no automatic recognition: a specific partner or regulator may set its own requirements for the standard, the certification body and accreditation. We check these conditions before the project starts.

For registration abroad, a copy of the certificate is usually notarized and apostilled by the state authority of the country where it was issued. If needed, we arrange an apostille and translation of documents as a separate service.

Every certificate has a unique number. First, find it in the certification body’s register. There, the certificate must be shown as valid, and the organization name, address, standard, certification scope and issue date must match the certificate itself.

For an accredited certificate, also check the certification body itself and its scope of accreditation. International certificates are also visible in IAF CertSearch if the certification body has submitted the data there. Once the certification body issues your certificate, we will send you instructions and a link for verification.

An ISO 13485 certificate does not replace CE marking. Under MDR 2017/745 and IVDR 2017/746, you need a technical file, a clinical evaluation and, for most devices, a conformity assessment by a notified body, which audits the QMS itself. A notified body is not required only for class I devices, except reusable surgical instruments, sterile devices and devices with a measuring function, and under the IVDR, for non-sterile class A devices.

A QMS under ISO 13485 is the basis for this assessment: EN ISO 13485 is one of the harmonized standards under the MDR and IVDR. We prepare you for ISO 13485 certification and help you build a path to CE marking through our partners in the EU.

Hiring a dedicated full-time specialist is usually not necessary. The company appoints one or more responsible employees who know production and can maintain the system after certification.

We develop the documentation, often from scratch, assign roles, train the responsible employees and support the team through the certification audit.

After the initial audit, the certification body carries out annual surveillance audits. The company continues to keep records, update documents, conduct internal audits and post-market surveillance, and correct any nonconformities found.

Before the end of the three-year cycle, the certification body conducts recertification. We remind you of key dates in advance. Annual surveillance is a separate paid service of the certification body and is not included in the cost of the initial certification project.

The certificate states the certification scope: the specific activities it covers. If several company sites fall within this scope (for example, production and a separate warehouse), the auditor checks each of them, and all of them are listed on the certificate, usually in an appendix.

If the certified activities take place at one site, only that site is listed on the certificate. We clarify the list of sites at the start of the project so that the certification body includes them in the audit plan right away and you do not have to pay extra later.

Yes, if the certificate is valid and was issued by an internationally accredited body (Global ACI MRA, formerly IAF MLA). This is usually needed when the previous body no longer works with the company or the certificate is about to expire.

We check the certificate status, its scope and the surveillance already completed, and then assess whether a transfer is possible. If it is not, we plan initial certification with the new body and coordinate the dates so that your certification stays uninterrupted for contracts and tenders.