Certified Medical Device Quality Professional (CMDQP)

Certified Medical Device Quality Professional (CMDQP) Certification Program by Tonex

Build end-to-end mastery of medical device quality systems that meet ISO 13485, FDA 21 CFR 820, and EU MDR expectations. This program guides you through QMS design, documentation control, design controls, validation, supplier quality, internal audits, CAPA, and certification readiness.

You will practice structuring evidence, traceability, and risk files that withstand rigorous inspections while enabling faster, compliant releases. Cybersecurity impact is emphasized across lifecycle processes to protect design history, production data, and postmarket signals. You will align quality, regulatory, engineering, and cybersecurity teams to manage changes safely and sustain audit-ready operations.

Learning Objectives

• Establish a compliant, scalable medical device QMS
• Organize documentation, records, and traceability matrices
• Implement risk management integrated with design controls
• Plan process validation, supplier controls, and acceptance activities
• Run internal audits and CAPA programs that drive real improvement
• Prepare objective evidence for certification and notified body reviews
• Strengthen product lifecycle with cybersecurity risk controls and secure data integrity

Audience

• Quality Managers and Engineers
• Regulatory Affairs Specialists
• R&D and Design Assurance Engineers
• Manufacturing and Operations Leaders
• Clinical and Postmarket Surveillance Teams
• Cybersecurity Professionals
• Compliance, QA/RA Consultants

Course Modules

Module 1: QMS Foundations and Regulatory Landscape

• ISO 13485 scope, structure, intent
• FDA 21 CFR 820 expectations
• EU MDR quality system touchpoints
• Quality policy, objectives, metrics
• Roles, responsibilities, governance
• Documented information hierarchy

Module 2: Documentation Control and Records Management

• DHF, DMR, DHR relationships
• Change control and approvals
• Records retention and retrieval
• Data integrity and traceability
• Templates, forms, and workflows
• Supplier and partner documentation

Module 3: Risk Management and Design Controls

• ISO 14971 risk process
• User needs to design inputs
• Verification and validation plans
• Usability engineering alignment
• Risk files and residual risk
• Cybersecurity risk integration

Module 4: Production Process Validation Supplier Quality

• IQ OQ PQ strategies
• Process monitoring and SPC
• Incoming, in-process, final acceptance
• Supplier qualification and auditing
• Nonconformance handling and MRB
• Sterilization and environmental controls

Module 5: Internal Audits and CAPA Excellence

• Audit program planning and scope
• Audit checklists and sampling
• Findings, grading, and reporting
• Root cause analysis techniques
• CAPA effectiveness verification
• Trending, dashboards, management review

Module 6: Certification Readiness and Postmarket Surveillance

• Notified body engagement strategy
• Technical documentation readiness
• Objective evidence and traceability
• Complaints, vigilance, reporting
• PMS plans and clinical evaluation
• Continuous improvement roadmap

Exam Domains

1. Regulatory Strategy and Compliance Governance
2. Quality Risk Analytics and Decision Making
3. Data Integrity, Traceability, and Evidence
4. Audit Program Design and Execution
5. Corrective and Preventive Action Systems
6. Certification Pathways and Readiness Management

Course Delivery
The course is delivered through a combination of lectures, interactive discussions, case studies, and project-based learning, facilitated by experts in the field of Certified Medical Device Quality Professional. Participants will have access to online resources, including readings, examples, and tools for practical exercises.

Assessment and Certification
Participants will be assessed through quizzes, assignments, and a capstone project. Upon successful completion of the course, participants will receive a certificate in Certified Medical Device Quality Professional.

Question Types

• Multiple Choice Questions (MCQs)
• Scenario-based Questions

Passing Criteria
To pass the Certified Medical Device Quality Professional Certification Training exam, candidates must achieve a score of 70% or higher.

Ready to build an audit-ready QMS that accelerates compliant innovation Join the CMDQP program by Tonex and elevate your quality, regulatory, and cybersecurity outcomes.