Admission requirement is the successful qualification “Expert Quality Management Medical Devices International (TÜV)” as well as 2 years professional experience in the medical device industry or in carrying out audits in other industries.

Successful participation in the TÜV Rheinland Akademie training course “1st and 2nd Party Auditor Medical Devices International (TÜV)” recognized by the certification body. Admission to the exam is granted upon a minimum attendance of 80% of the 3 module training programme.

• Written exam (Multiple Choice)

In the written examination participants prove their knowledge in the following areas:

• Outsourcing of processes in the medical product industry
• Validation of processes in the medical product industry
• Regulations, requirements of auditors and process of audits

“1st and 2nd Party Auditors Medical Devices International (TÜV)” can plan, prepare, carry out and evaluate internal and supplier audits in the medical product industry.