2017-2018 Academic Catalog 
    
    Mar 29, 2024  
2017-2018 Academic Catalog [ARCHIVED CATALOG]

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MEDDV 104 - Design and Manufacturing in Medical Devices



3.0 Credits
Overview of fundamental systems used in the design, development, and manufacturing of medical devices. Covers material and process selection; aseptic processes; clinical testing; introduction to automation/ control systems; testing/instrumentation lab; manufacturing controls.
Course-level Learning Objectives (CLOs)
Upon successful completion of this course, students will be able to:

  1. Explain the design process and the definition of design within the medical device sector.
  2. Describe uses for which products could be designed and analyze the steps involved in the design process.
  3. Define, describe and list product specifications, analyze design requirements and determine the types of files required including the design history file (DHF), the device master record (DMR) and the design history record (DHR).
  4. Describe and explain the process selection and monitoring process validation in the design and manufacturing of medical devices.
  5. Determine and demonstrate how a design requirement is verified.
  6. Analyze and determine how customer needs are validated.
  7. Explain production and manufacturing scale up.
  8. Describe the process of post market surveillance including the customer complaint process; criteria for reporting to the FDA and criteria for product recalls.
  9. Explain the Corrective and Preventive Action (CAPA) process.



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