Certus Medical Device Quality Management System (MDD-QMS) auditor certification provides the rigor and validity to demonstrate your knowledge, skills, and competence to a global audience at a low price with no hassles and no extra fees. Just pay a low application fee and a low annual certification fee. No exam fees, no behavioral assessments. Plus, you can save up to 30% more with our multiple certification discount and senior discounts.
The Certus MDD-QMS auditor certification program is designed for auditors who conduct MDD-QMS audits of organizations based on ISO 13485:2016.
Organizations audited typically provide medical devices and related services, including those involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support).
This certification is designed for:
- MDD-QMS auditors, such as those employed by third-party certification bodies/registrars or by purchasing organizations (second-party auditors)
- Medical device quality management practitioners, such as medical device quality management consultants, quality managers, and third-party certification managers
- Employees conducting medical device quality management system audits within their own organizations (internal audits)
GRADES AVAILABLE FOR THE MDD-QMS AUDITOR CERTIFICATION
A grade is a specific level within a personnel certification program that best describes the job role for that certification program. Available grades for the Certus MDD-QMS auditor certification are:
- Provisional Auditor: For those who have completed an auditor training course, but who do not yet meet the audit requirements of their desired grade. You may maintain provisional auditor certification for up to two years. After which, you must transition to a higher grade to maintain your certification. This is a good way to begin your auditing career as it gives you formal recognition of your training and abilities.
- Auditor: For those who audit solo or as a member of an audit team.
- Lead Auditor: For those who lead audits and audit teams.
- Master Auditor: For experienced auditors with at least ten years of lead auditor experience. This grade is for senior audit professionals with an extensive history of conducting audits, but who may no longer lead teams or audit regularly. Master auditors may move into training, consulting, or management roles.