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Oct 23, 2026
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BMED 2500 - Introduction to Documentation/Configuration Management
Credits: 3
Catalog Description
This course is geared towards individuals and/or teams interested in establishing and managing documentation and related systems in the area of medical device manufacturing. The curriculum introduces students to the fundamentals of governmental requirements that impact medical device documentation, the benefits and elements of a documented configuration management system, and the details to establish related systems, policies, procedures, and tools.
Recommended Skills, Abilities, or Coursework: BMED 2200
Additional fee to student: No
Learner Outcomes
- Explain the definition of a medical device and related terminology.
- List the benefits, scope and elements of medical device documents and configuration management control systems.
- Analyze governmental regulations and implications in establishing and maintaining a configuration management system in a global market.
- Interpret 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 document/configuration management.
- Compare the requirements of the Quality System Regulations (QSRs), Quality Manual, associated Standard Operating Procedures (SOPs), and lower level documentation
- Classify management responsibilities as they relate to document/configuration management.
- Explain the elements of configuration management including design and development of a document change control system.
- Demonstrate the change request process, including document creation/markup, interchangeability, document structuring, life cycles/workflows, auditing, etc.
- Identify the importance and benefits of a well-designed employee training and communication system.
- Name online resources regarding configuration management.
Major Areas of Course Content
- Introduction to medical device industry
- Configuration management
- Overview of U.S. governmental regulations
- Overview of international governmental regulations
- Configuration management organization/responsibilities
- Quality management system procedure development
- Employee training/access/authorization/regulatory auditing
- Document control elements: preparation/format/content
- Document control elements: review/voting/release/distribution/access/retrieval/security/storage/retention/disposal
- Document change control work flow/life cycle - creation
- Document change control work flow/life cycle - review through disposition
- Document change request creation
- Introduction to automated document control systems
Credit for Prior Learning Options
No credit for prior learning option is available for this course.
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