MEDDV 110 - Introduction to Documentation/Configuration Management

1. Describe the scope and benefits of a medical device documentation / configuration management control system. [COMMUNICATE]
2. List and describe the elements of configuration management including design and development of a document change control system. [COMMUNICATE]
3. Demonstrate a global understanding of the governmental regulations and implications in establishing and maintaining a configuration management system. [EXPLORE]
4. Explain the ramifications of noncompliance. [REASON]
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. [REASON]
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. [COMMUNICATE]
7. Describe management responsibilities related to documentation / configuration management. [COMMUNICATE]