Feb 05, 2025  
2024-2025 Academic Catalog 
  
2024-2025 Academic Catalog
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BMED 2320 - Quality Management for Medical Devices


Credits: 3

This course defines the role of quality also referred to as performance excellence in a business environment, as it is applied within the Medical Device industry in relation to ISO 13485 and FDA Quality System Regulations. Topics include the use of quality management techniques and quality philosophies, organization and process development for quality, techniques used in process design and improvement, approaches used in continuous improvement, methods used to control quality. The course includes organizational design and leadership concepts in achieving quality services and products.

Recommended Skills, Abilities, or Coursework: BMED 2300 



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