What Will You Learn?

• By the end of this course, participants will be able to:
• Understand the structure and requirements of ISO 13485:2016
• Implement and maintain a compliant QMS for medical devices
• Align internal processes with regulatory and customer requirements
• Apply risk-based thinking to product design and manufacturing
• Ensure traceability, process validation, and device safety
• Conduct audits, management reviews, and improvement planning
• Prepare for ISO 13485 certification or surveillance audits

Material Includes

• Participants will receive:
• ISO 13485:2016 training manual
• Clause-by-clause interpretation guide
• Sample QMS documentation and templates
• Audit checklist and internal audit tools
• Risk management and CAPA templates
• Case studies and practical scenarios
• Practice questions and exam prep guide
• Certificate of completion (where applicable)

Audience

• This course is ideal for:
• Quality Managers and QMS Implementers in medical device companies
• Regulatory Affairs Specialists
• Internal and Lead Auditors
• R&D and Product Design Engineers
• Operations and Manufacturing Managers
• Compliance Officers and Consultants
• Professionals seeking ISO 13485:2016 certification