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May 04, 2024
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MEDDV 110 - Introduction to Documentation/Configuration Management
3.0 Credits Covers fundamentals of governmental requirements that impact medical device documentation, benefits and elements of a documented configuration management system, and steps taken to establish related systems policies, procedures and tools. Course-level Learning Objectives (CLOs) Upon successful completion of this course, students will be able to:
- Describe the scope and benefits of a medical device documentation / configuration management control system.
- List and describe the elements of configuration management including design and development of a document change control system.
- Demonstrate a global understanding of the governmental regulations and implications in establishing and maintaining a configuration management system.
- Explain the ramifications of noncompliance.
- 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.
- 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.
- Describe management responsibilities related to documentation / configuration management.
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