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.
FDA proposed changes to ISO 13485: 2015 and Medical Devices Quality Management Systems covers topics such as:
- 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
FDA proposed changes to ISO 13485: 2015 and Medical Devices Quality Management Systems brings together 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
