Medical Devices Quality Management System – Implementer Certification

This implementer 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 competence to design, implement, operate, and continually improve a ISO 13485:2016-conformant Medical Devices Quality Management System within an organization, including gap analysis, documentation development, and preparing for certification audits.

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:

• ✓Design and implement a ISO 13485:2016-conformant management system
• ✓Conduct gap analyses against ISO 13485:2016 requirements
• ✓Develop documentation architecture and process maps
• ✓Establish monitoring, measurement, and evaluation systems
• ✓Prepare the organization for certification readiness

Eligibility Requirements

Competency Framework

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

• ▶Gap analysis and readiness assessment against ISO 13485:2016
• ▶Management system design and documentation development
• ▶Process mapping and operational control implementation
• ▶Performance monitoring and measurement system design
• ▶Internal communication and change management for MDQMS

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