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Effective: Summer 2014

Grade Type: Letter Grade Only
Not Repeatable.
FHGE: Non-GE Transferable: CSU
5 hours lecture. (60 hours total per quarter)

Student Learning Outcomes -
  • Students who successfully complete this course should be able to identify a medical device based on its functions.
  • Students who successfully complete this course should be able to identify major elements of medical device documents.
Description -
This course focuses on establishing and managing documentation and related systems in the area of medical device manufacturing. 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 and tools.

Course Objectives -
The student will be able to:
  1. Explain the definition of a medical device and related terminology.
  2. List the benefits, scope and elements of medical device documents and configuration management control systems.
  3. Analyse governmental regulations and implications in establishing and maintaining a configuration management system in global market.
  4. Interpret specific Food and Drug Administration Regulations and European Medical Devices Directives related to document / configuration management.
  5. Compare the requirements of the Quality System Regulations, Quality Manual, associated Standard Operating Procedures and lower level documentation.
  6. Classify management responsibilities as they relate to document/configuration management.
  7. Explain the elements of configuration management including design and development of a document change control system.
  8. Demonstrate the change request process, including document creation/markup, interchangeability, document structuring, life cycles / workflows, auditing, etc.
  9. Identify the importance and benefits of a well designed employee training and communication system.
  10. Name online resources regarding configuration management.
Special Facilities and/or Equipment -

Course Content (Body of knowledge) -
  1. Introduction to configuration management
    1. History of configuration management
    2. Document control function responsibilities
    3. Distributed configuration management
    4. Manager of configuration management
  2. Product documentation
    1. Formats and Standards
    2. Controlled engineering parts list
    3. Units of measure
    4. General specification
    5. Process design specifications
    6. Document groups and control
  3. Identification numbers
    1. Product numbers and model numbers
    2. Par number cycle
    3. Version numbers
    4. Traceability
    5. Serial numbers
    6. Part numbers
    7. Classification coding
    8. Naming convention
    9. Sketch numbers
    10. Part number assignment
    11. Revision numbers and letters
    12. Item marking
    13. Labels and stickers
  4. Bill of Material
    1. Data dictionary
    2. Item master file
    3. Design engineering data
    4. Marked-up parts list
    5. Manufacturing data
    6. System item codes
    7. Design for modularity
    8. Modular parts list
  5. Document release and product lifecycle
    1. Lifecycle release phases
    2. Documents tied to the release phase
    3. The revision block
    4. Lifecycle phase issues
    5. Baseline-lifecycle phase relationships
    6. Product production phase
    7. Management of the release process
    8. Release status codes
    9. Release form and signatures
    10. Release checklist
  6. Process standard and audits
    1. Writing and formatting standards
    2. Best practice for a Standard
    3. Subjects to Standardize
    4. Procedures
    5. Procedure in a flow diagram
    6. Standards manual
    7. Training
    8. Auditing plan, frequency and follow up
Methods of Evaluation -
  1. Oral presentation
  2. Group discussion
  3. Class participation
  4. Midterm examination
  5. Final examination
Representative Text(s) -
Frank B. Watts, Engineering Documentation Control Handbook, Fourth Edition: Configuration Management and Product Lifecycle Management, 2011. ISBN 1455778605

Disciplines -
Method of Instruction -
Lecture and group discussion.
Lab Content -
Not applicable.
Types and/or Examples of Required Reading, Writing and Outside of Class Assignments -
  1. Reading Assignments
    1. Suggested supplemental readings from articles relevant to course material
    2. Suggested supplemental reading of case studies
    3. Suggested supplemental readings from web searches relevant to course material
  2. Writing Assignments
    1. Question sets based upon assigned reading on current research topics.
    2. Weekly problem sets.