ISO 13485 Certifications

Validate that you have the ability to successfully develop a medical devices management system with the PECB ISO 13485 Certification.

Guide your organization in using the ISO 13485 standard to develop medical devices, which will make your company competitive in today’s global market.

Check below to find the certification that suits you best!

ISO 13485 Foundation

The ISO 13485 Foundation certification is a professional certification for professionals needing to have an overall understanding of the ISO 13485 standard and its requirements.
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ISO 13485 Lead Implementer

The ISO 13485 Implementer certifications are professional certifications for professionals needing to implement a Quality Management System (MDQMS) and, in the case of ISO 13485 Lead Implementer Certification, manage an implementation project.
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ISO 13485 Lead Auditor

The ISO 13485 Lead Auditor certification is a credential for professionals needing to audit a Medical Devices Quality Management System (MDQMS) and, able to manage a team of auditors.
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