Table of Contents:
- Introduction (definition, types of medical devices, regulatory background)
- Quality Management System
- Design control
- Human factors
- Statistical techniques
- Risk management
- document and record control
- production and process controls
- identification and traceability
- buildings, facilities and equipment
- purchasing/supplier control
- packaging and labeling
- handling, storage, distribution, installation and servicing
- nonconformance, corrective action and preventive action
- customer complaints
- combination products
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