Medical Device Manufacturing: Processes & Practices

The medical device industry is growing with over 100 established companies in the state of Utah! The Medical Device Manufacturing: Processes and Practices certificate program includes a series of courses addressing the competencies outlined by the medical device industry and covers basic core knowledge and skills required for entry-level positions.  Each course content aligns with national industry-recognized standards.

This industry is highly regulated by the Food and Drug Administration (FDA) and medical device companies must ensure their products are safe and effective for consumers. Employees working in the industry should be trained with specific knowledge and skills in areas such as data management and analysis; Good Manufacturing Practices (GMP); FDA regulations; Total Quality System (TQS); and, Good Documentation Practices (GDP). A core knowledge and skills certificate will be awarded upon the successful completion of the 4 core courses: CEMD 0910, 0920, 0930, and 0940. Learn more about certificate options here.

As of January 2016, two additional courses were added to the program - 0950 Intro to Quality Concepts and 0960 QA Auditing Concepts.  These courses are not part of the certificate. 

This training is appropriate for those new to the industry, transitioning from a related discipline or professionals wanting refresher courses.

Click here for printable downloadable Current Schedule PDF.

Visit the website for the National Center for the Biotechnology Workforce  

Press Release by The Manufacturing Institute:  http://www.themanufacturinginstitute.org/~/media/5F20A80BCC75420DAE742F7DA6336AEE/SLCC_PR.pdf

Spotlighting Educators:  http://www.themanufacturinginstitute.org/Skills-Certification/Educator-Resources/Best-Practices/Spotlights.aspx

The Manufacturing Institute Releases Third Spotlight on Community College Consortium:  http://www.themanufacturinginstitute.org/News-Articles/2016/06/03-SLCC.aspx

 

 

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Courses

Basic Manufacturing Skills

CEMD 0920
This course focuses on fundamental principles of measurement, performing measurements, data management and analysis related to medical device manufacturing.   Mastery of these skills is key to...

Intro Medical Device Industry

CEMD 0910
This course provides an overview of the medical device industry, particularly in Utah.  It will address topics including diversity of products, size and scope of the industry, current trends, and the...

Intro to FDA Regulations

CEMD 0930
This course introduces the regulations governing the life science industry with emphasis on those that impact medical device development and manufacturing.  A thorough understanding of FDA...

Intro to Quality Control - Now offered Online

CEMD 0950
This course explores the concepts and tools used by quality control technicians in the life sciences including medical devices, pharmaceuticals and nutritional supplements.   A broad overview of...

Intro to Quality Systems

CEMD 0940
In this course students will master competencies related to the regulation and medical  device quality systems.  In particular, students will be able to describe regulations 21 CFR 820 ISO1345 and...

QA Auditing Concepts

CEMD 0960
This course is an introduction to the field of auditing concepts. Students will gain a basic foundational knowledge to quality auditing in the medical device industry.  This course will explore...