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    15 credit hours

Medical Quality Systems

  • Medical Quality Systems
    Certificate without Financial Aid Eligibility


    Effective Beginning Catalog Term: Fall 2013 (475)

    The requirements shown below are valid beginning Fall 2013 (475), and may not reflect degree requirements for current students. Current students should visit My SPC and view My Learning Plan to see specific degree requirements for their effective term.

    Program Leadership Information

    Lara Sharp, Program Director, (727) 398-8256

    Program Summary


    This program was developed for the Medical Device Industry Education Consortium (MDIEC) Project under the National Science Foundation (NSF) Advanced Technological Consortium (ATE) Program to meet the critical industry-specific educational needs in quality assurance and present the regulatory and quality standards that are required for the medical device industry.

    MDIEC was formed to build a national learning and innovation network to develop and deliver industry-endorsed solutions that address critical industry-defined technical education and training needs.

    The courses in this certificate program will be part of the Biomedical Systems specialty of the Associate in Science degree in Engineering Technology.

    Certificate Outcomes:
    o Evaluating the quality system as it conforms to FDA regulatory requirements
    o Identifying medical device-related risk assessment and evaluation
    o Integration of medical device manufacturing strategies
    o Evaluating corrective action plans
    o Using quality auditing tools and techniques

    The Academic Pathway is a tool for students that lists the following items:
    o the recommended order in which to take the program courses
    o suggested course when more than one option exists
    o which semester each course is typically offered
    o if the course has a prerequisite
    o courses that may lead to a certificate (if offered in the program)

    If you are starting the program this term, click here to access the recommended Academic Pathway.

    If you have already started the program, click here for the archived Academic Pathways.

    Please verify the Academic Pathway lists your correct starting semester.

    Florida CIP Code


    Federal CIP Code

    41.0101: Biology Technician/Biotechnology Laboratory Technician.

    Job Related Opportunities

    • Quality Specialist
    • Quality Assurance Technician
    • Manufacturing Technician
    • Production Technician
    • Quality Systems Auditor
    • Quality Compliance Specialist


    ETI 1030Regulatory Environment for Medical Devices3
    ETI 2031Risk Management and Assessment for Medical Devices3
    ETI 2032Change Control and Documentation3
    ETI 2041Medical Device Design and Manufacturing3
    ETI 2171Quality Auditing for Medical Devices3
    Total Credits15
  • CT iconFrom insulin pumps to discreet heart monoitors to artificial hips and legs, technology and biomedical research will continue to transform modern healthcare. To bring these innovative designs to patients, medical device manufacturers need highly qualified employees. Our certificate and A.S. degree programs teach you the methods and technology used in designing, regulating and manufacturing medical devices that use the latest medical technology.

  • What you will learn

    • Food and Drug Administration regulations for biomedical systems
    • How to evaluate a quality system regarding FDA regulatory requirements
    • Medical device design and manufacture
    • Document and data management control
    • Risk assessment and evaluation of medical device production
    • Integration of medical device manufacturing strategies
    • Corrective action plans
    • Use of quality auditing tools and techniques
  • Continuing your education

    This certificate is part of and applies towards the Biomedical Systems specialization of the A.S. Degree in Engineering Technology.

    CT to AS to BAS icon 

  • Careers

    • The biomedical field is one of the fastest growing in the country and grew 12 to 16 percent during the recent recession.
    • In the United States, Florida ranks second behind to California in the number of FDA-registered medical device manufacturing companies.
    • Statewide, 575 medical device manufacturers employ nearly 19,000 workers at an average wage of $61,413.
    • Tampa Bay is second in the state in its number of medical device companies.

    Our program prepares you for the following careers:

  • Facilities

    A long-time leader in workforce education, St. Petersburg College developed the Tampa Bay area’s first Collaborative Center for Emerging Technologies as an open manufacturing factory work environment to simulate skills needed in emerging technologies in August, 2012.

    SPC's SolidWorks Design Center was the first of its kind in Florida developed through the collaborative efforts of local industry and makes use of Computer Numerical Control (CNC) equipment, 3-D scanners and 3-D printers.

    In all, SPC has four state-of-the-art labs, including additive manufacturing-rapid prototyping, quality measurement and electronic instrumentation.

    Biomedical facilities  Electronics students 
    Electronics  Engraving 
  • Program Dir, Engineering Tech