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
