Medical Devices Quality Management System – Associate Certification

This associate level certification validates foundational to advanced competence in Medical Devices Quality Management System. Professionals certified at this level demonstrate comprehensive understanding and practical application of Medical Devices Quality Management System requirements and principles within their organizations.

This certification scheme validates awareness-level competence in ISO 13485:2016 MDQMS requirements. Certified professionals demonstrate the ability to support Medical Devices Quality Management System activities, understand key concepts, and contribute to compliance monitoring tasks under supervision.

Who Is This For?

Purpose & Objectives

This certification program is designed to validate your competence and knowledge of Medical Devices Quality Management System requirements. Upon completion, you will be able to:

• ✓Support MDQMS activities under supervision
• ✓Contribute to compliance monitoring and documentation
• ✓Understand practical application of ISO 13485:2016 requirements
• ✓Assist in maintaining management system records
• ✓Participate effectively in MDQMS team activities

Eligibility Requirements

Competency Framework

Candidates for the Associate certification in Medical Devices Quality Management System must demonstrate competence in:

• ▶Practical understanding of ISO 13485:2016 requirements
• ▶Ability to support MDQMS activities under supervision
• ▶Competence in compliance monitoring tasks
• ▶Understanding of documentation and record maintenance
• ▶Ability to contribute to MDQMS team objectives

Assessment & Examination

• ✓Multiple-choice examination format
• ✓Minimum passing score: 70%
• ✓Online proctored examination available
• ✓Results provided within 48 hours

Certificate Validity & CPD

• ✓Certificate validity period: 3 years from date of issue
• ✓Continuing Professional Development (CPD) required for renewal
• ✓Minimum 15 CPD hours per year in relevant domain
• ✓Recertification examination or portfolio assessment at renewal
• ✓Digital certificate and verification via QA Assessor registry

Code of Conduct

All certified professionals must adhere to the QA Assessor Code of Conduct:

• ▶Acting with integrity, objectivity, and professional competence
• ▶Maintaining confidentiality of all information obtained during professional activities
• ▶Reporting any conflicts of interest or ethical concerns
• ▶Committing to continuous professional development
• ▶Upholding the reputation of the certification and the profession