Certified Internal Auditor for Medical Devices (CIAMD)

Certified Internal Auditor for Medical Devices (CIAMD) Certification Program by Tonex

This program builds deep capability in planning, conducting, and improving internal audits for medical device organizations aligned with ISO 13485 and related regulatory systems. Participants learn to translate standards into practical audit criteria, assess risk, evaluate documented information, and report findings that drive corrective and preventive action.

Emphasis is placed on lifecycle controls spanning design, production, post market surveillance, and supplier quality to ensure safe and effective devices reach patients. The program also addresses data integrity, secure recordkeeping, and digital traceability across QMS processes. Cybersecurity risks affecting product safety and QMS reliability are discussed with actionable approaches to integrate controls into audit scope. Cybersecurity posture is reviewed as part of audit planning, execution, and follow up to protect sensitive data and maintain trust with regulators and customers.

Learning Objectives

• Plan and scope audits aligned with ISO 13485 requirements
• Evaluate QMS processes using risk based thinking and evidence
• Analyze nonconformities and verify corrective and preventive actions
• Assess supplier controls and design transfer effectiveness
• Write clear audit reports that enable management decisions
• Improve audit programs using metrics and continual improvement
• Understand cybersecurity impacts on QMS evidence and product safety

Audience

• Quality Assurance Managers
• Internal Auditors and Lead Auditors
• Regulatory Affairs Professionals
• Manufacturing and Operations Leaders
• Design and Development Engineers
• Supplier Quality and Procurement Teams
• Cybersecurity Professionals

Program Modules

Module 1: Audit Foundations for ISO 13485

• Audit terms and principles
• Process and risk based auditing
• ISO 13485 clause mapping
• Roles responsibilities ethics
• Evidence sampling techniques
• Audit trails and traceability

Module 2: Planning and Program Management

• Annual audit program design
• Risk prioritization and criteria
• Audit plans and checklists
• Auditor competence and training
• Schedule resourcing escalation
• Program metrics and reviews

Module 3: Conducting the Audit Onsite

• Opening meetings expectations
• Interview and observation skills
• Document and record review
• Sampling production and testing
• Supplier and outsourced processes
• Closing meeting and consensus

Module 4: Reporting and Nonconformities

• Classifying audit findings
• Writing clear objective evidence
• Root cause and containment links
• CAPA verification and closure
• Report structure and timelines
• Management communication tactics

Module 5: Risk Controls and Cybersecurity

• Risk files and risk registers
• Software lifecycle and validation
• Data integrity and access control
• Product and QMS cybersecurity scope
• Post market surveillance signals
• Change control and re audit triggers

Module 6: Integration with Regulations

• ISO 14971 risk alignment
• FDA QMSR EU MDR linkage
• UDI and traceability checks
• Supplier regulatory expectations
• Complaint vigilance recall flow
• Continuous improvement roadmap

Exam Domains

1. Principles of Medical Device Auditing
2. Audit Program Governance and Metrics
3. Risk Based Planning and Scoping
4. Audit Execution Evidence and Sampling
5. Reporting Findings CAPA and Follow Up
6. Regulatory Integration and Data Integrity

Course Delivery
The course is delivered through a combination of lectures, interactive discussions, and project based learning facilitated by experts in medical device quality and auditing. Participants access online resources including readings, case studies, and practical tools to apply concepts immediately at work.

Assessment and Certification
Participants are assessed through quizzes, assignments, and a capstone project. Upon successful completion, participants receive the Certified Internal Auditor for Medical Devices CIAMD certificate by Tonex.

Question Types

• Multiple Choice Questions MCQs
• Scenario based Questions

Passing Criteria
To pass the Certified Internal Auditor for Medical Devices CIAMD Certification Training exam, candidates must achieve a score of 70% or higher.

Ready to elevate your internal audit capability and strengthen device quality Contact Tonex to enroll in the CIAMD program and secure your seat today.