FDA proposed changes to ISO 13485: 2015 and Medical Devices Quality Management Systems

FDA proposed changes to ISO 13485: 2015 and Medical Devices Quality Management Systems is an event dedicated to insight into the specific auditing requirements of the International ISO 13485 Standard requirements for medical devices.

Topics

• How to carefully attend to every aspect of the related biomedical standards
• Requirements of ISO 13485
• Purchasing Controls
• Document control
• CAPA
• Production controls
• Upcoming changes ISO 13485:2015
• Identification and Traceability
• Regulatory expectations of other major growing geographies in the world
• How ISO 13485 differ from FDA QSR 21 CFR 820 requirements

Who should Attend

Senior attendees involved or interested in:

• Regulatory Affairs
• Quality Assurance
• Quality Control
• Research & Development
• Documentation
• Supplier Management
• Internal Auditors
• Production
• Supplier Auditors
• Quality Auditors
• Manufacturing
• Operations
• Suppliers to medical device industry