Do you audit ISO 138485-based medical device systems? Want to demonstrate that you are a medical device expert?

Exemplar Global’s Medical Device ISO 13485:2016 Auditor certification program can give you the international recognition you need to stand out from the crowd.

Through extensive examination of your knowledge, work experience, and competence to audit, Exemplar Global Medical Device Auditor certification can give you proof of your competence to effectively audit medical device systems.

Aligned with ISO 13485:2016, Exemplar Global’s Medical Device Auditor certification aims to develop and certify confident and reliable auditors for the medical device Industry. Detailed knowledge of the audit process and international standards and direct auditing experience are required to achieve certification to this program.

The program provides international recognition for auditors who conduct medical device audits using national, international management system standards (e.g., ISO 13485:2016), or other management system standards and normative and industry references that are recognized by Exemplar Global.

So what are you waiting for? Download the requirements and click “Apply Now” to get started.

Program Objectives

Exemplar Global’s Medical Device personnel certification program has been developed to:

  • Achieve the requirements of the international standard for personnel certification, ISO/IEC 17024:2012.
  • Ensure that auditors meet or exceed the qualification guidelines for management system auditors described in ISO 19011:2011 and ISO 13485:2016 and are assessed as competent to perform medical device audits.
  • Assist organizations in identifying or documenting appropriately qualified auditors.
  • Enhance the professional knowledge, reputation, and recognition of qualified auditors.