quality management system for medical devices
ISO 13485 certificates in Europe
Recertia follows 46 companies in Europe with a valid ISO 13485 certificate. 10 of their certificates expire in the next 6 months - the period when companies prepare for the recertification audit.
Certificates expiring in the next 12 months
ISO 13485 certificates by country
About ISO 13485
ISO 13485 sets requirements for a quality management system of companies that design, make or supply medical devices.
The current edition is ISO 13485:2016.
A certificate is valid for three years. Surveillance audits take place in the first and second year; before the certificate expires the company goes through a recertification audit.
Sample from the base
| Company | Country | Expires |
|---|---|---|
| s•••••.se | Sweden | Dec 2026 |
| i••••••••.cz | Czechia | Dec 2026 |
| f••••••.se | Sweden | Feb 2027 |
| 1••••••••.nl | Netherlands | Feb 2027 |
| q•••.nl | Netherlands | Feb 2027 |
Company names are hidden. A full record includes the company name, website, standard, certification body, validity date and a link to the document.
Questions
How long is an ISO 13485 certificate valid?
Three years, provided the yearly surveillance audits are passed. Before expiry the company needs a recertification audit to receive a new certificate.
How can I check whether an ISO 13485 certificate is valid?
Check the holder, scope and validity date on the certificate, then confirm with the certification body that issued it. Our guide walks through the steps.
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