ISO 13485 Certification

Information Meeting and Pre-Audit (Optional)
We start with an informational meeting, either by telephone or in person, to discuss your project and prepare you for ISO 13485 certification. Relevant documents related to your quality management system for medical devices will be reviewed. Optionally, a pre-audit can be performed to assess the current status of your processes.

On-Site or Remote Certification Audit
Our auditors evaluate your company’s readiness for certification. This includes assessing your quality management system, reviewing documented processes, and verifying compliance with medical device regulations. If necessary, corrective actions are reviewed in a follow-up audit.

Audit Report and Evaluation
After the audit, we provide a detailed report assessing the effectiveness of your quality management system and identifying areas for improvement.

Certification
Upon successful completion of the audit, you will receive your ISO 13485 certificate, valid for up to three years.

Surveillance Audits
To ensure ongoing compliance with medical device regulations, we conduct regular surveillance audits throughout the certification period.

Recertification
Before the certificate expires, a recertification audit is conducted to confirm long-term compliance and maintain the benefits of ISO 13485 certification.