ISO 13485:2016 Foundation Training

About the Training

ISO 13485:2016 is a quality management system standard designed for medical device manufacturers and suppliers. This training covers the structure, core requirements, and relationship of the standard with medical device regulations (EU MDR/IVDR, FDA).

Who Should Attend?

• Employees of medical device manufacturers or suppliers
• Quality assurance and regulatory compliance personnel
• Design and development teams
• Management system consultants

Training Content

• Structure of ISO 13485:2016 and differences from ISO 9001
• Medical device regulations: EU MDR, IVDR, FDA 21 CFR Part 820
• Risk management (ISO 14971) integration
• Design and development controls
• Supplier management and purchasing controls
• Validation and verification processes
• Certification and notified body process

Duration

1 day (8 hours)