Upon completion of this course, participants will be able to:

• Describe the purpose of ISO 13485:2016 and its relationship to global medical device regulations.
• Interpret the specific requirements for design control, sterile devices, and traceability.
• Apply the principles of auditing to a medical device manufacturing or service environment.
• Audit the application of risk management (ISO 14971) throughout the product lifecycle.
• Determine and audit compliance with relevant regulatory requirements (e.g., MDR, 21 CFR 820).
• Plan, conduct, and lead an effective ISO 13485 internal audit.
• Identify and document nonconformities specific to medical device quality and safety.
• Evaluate the effectiveness of processes for complaint handling and post-market surveillance.

• Quality Managers, Engineers, and Specialists in the medical device industry.
• Internal Auditors and Supplier Auditors for ISO 13485 certified organizations.
• Regulatory Affairs personnel requiring QMS audit knowledge.
• Design and Development Engineers responsible for compliance.
• Consultants involved in ISO 13485 implementation and auditing.
• Personnel responsible for risk management and post-market activities.

• Detailed Case Studies on Medical Device Recalls and Complaint Handling.
• Practical Exercises in Auditing Design History Files (DHF) and Risk Files.
• Group Discussions on regulatory compliance (MDR/FDA) during an audit.
• Role-Playing Interviews with R&D, Manufacturing, and Regulatory personnel.
• Simulated Audit Trail focused on Product Traceability.

Unit 1: The Regulatory Landscape and ISO 13485 Fundamentals

• Overview of ISO 13485:2016 and its link to regulations (FDA, EU MDR/IVDR, Health Canada).
• Understanding the process approach in the medical device context.
• Auditing the Quality Policy and Quality Objectives, and their link to product safety.
• The importance of Top Management commitment and regulatory compliance.

• Auditing the specific requirements for documentation and records (Device Master/History Record).
• Auditing the infrastructure and contamination control requirements.
• Auditing the implementation of ISO 14971 (Risk Management for Medical Devices).
• Understanding and auditing statutory and regulatory requirements for medical devices.

Unit 2: Audit Principles and Program Management for ISO 13485

• Applying ISO 19011 principles to the unique risks of medical device auditing.
• Defining the competence and qualification requirements for a medical device auditor.
• Establishing a risk-based audit program focusing on critical product realization processes.

Unit 3: Auditing Product Realization and Design Control

• Effective auditing of the Design and Development process (from planning to transfer).
• Auditing the verification, validation, and design review processes.
• Auditing the Purchasing and Control of Externally Provided Processes/Products.
• Auditing the process for medical device traceability and recall procedures.

Unit 4: Auditing Operations, Monitoring, and Measurement

• Auditing control of production and service provision, including sterile device controls.
• Auditing installation and servicing activities and their records.
• Auditing the handling of nonconforming product and release of product.

• Auditing the Complaint Handling process and regulatory reporting.
• Auditing Post-Market Surveillance and vigilance reporting procedures.
• Auditing the process for CAPA (Corrective and Preventive Action) and its effectiveness.

Unit 5: Reporting, Follow-up, and Regulatory Linkage

• Structuring the ISO 13485 audit report for internal and regulatory needs.
• Writing clear, factual, and regulatory-linked nonconformity statements.
• Presenting findings, particularly those impacting patient safety.

• Practical exercises in linking audit observations to specific regulatory requirements (e.g., FDA).
• Evaluating the effectiveness of risk control measures identified during the audit.
• Maintaining audit competence for evolving regulatory landscapes.