MEDDV 110 - Introduction to Documentation/Configuration Management

1. Describe the scope and benefits of a medical device documentation / configuration management control system.
2. List and describe the elements of configuration management including design and development of a document change control system.
3. Demonstrate a global understanding of the governmental regulations and implications in establishing and maintaining a configuration management system.
4. Explain the ramifications of noncompliance.
5. Identify the specific Food and Drug Administration (FDA) Regulations (current Good Manufacturing Practices (cGMPs)), ISO Standards (9001, 13485, and 14001) and European Medical Devices Directives (MDD) related to documentation / configuration management.
6. Explain the requirements of the Quality System Regulations (QSRs) as they relate to documentation / configuration management for medical devices; include the development of a Quality Manual, associated Standard Operating Procedures (SOPs) and lower level documentation.
7. Describe management responsibilities related to documentation / configuration management.