- Type Certification
- Cost Paid
Certified Medical Device Auditor
Issued by
APMG International
The badge holder has learned how to plan and perform and follow-up audits on quality management systems for medical devices. The badge holder is able to collect evidence for conformity/nonconformity and can communicate with the auditee in an efficient and professional way including catering to auditee's situations and mindsets. The badge holder is able to apply ISO 13485 requirements to specific cases and is be able to judge if the auditee´s implementation complies with the requirements or not.
- Type Certification
- Cost Paid
Skills
Earning Criteria
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Badge holders have passed a 2 hour, 75 question multiple choice exam, scoring 38 marks or more.
Standards
This International Standard specifies requirements for a quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices.
ISO 19011:2018 provides guidance on auditing management systems, including the principles of auditing, managing an audit programme and conducting management system audits, as well as guidance on the evaluation of competence of individuals involved in the audit process.