Brad Jenkins, Program Director, CL (727) 341-4378
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:
• Evaluating the quality system as it conforms to FDA regulatory requirements
• Identifying medical device-related risk assessment and evaluation
• Integration of medical device manufacturing strategies
• Evaluating corrective action plans
• Using quality auditing tools and techniques
Job Titles:
• Quality Specialist
• Quality Assurance Technician
• Manufacturing Technician
• Production Technician
• Quality Systems Auditor
• Quality Compliance Specialist
APPROVED REQUIREMENTS FOR STUDENTS WITH CATALOG YEAR
20081/0400 (BEGINNING 8/25/2008) OR LATER
~ REFER TO CURRICULUM FILES FOR PREVIOUS CATALOG YEAR REQUIREMENTS ~
PROGRAM REQUIREMENTS |
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| ETI 1030 | REGULATORY ENVIRONMENT FOR MEDICAL DEVICES | 3 |
| ETI 2031 | RISK MANAGEMENT AND ASSESSMENT FOR MEDICAL DEVICES | 3 |
| ETI 2032 | CHANGE CONTROL AND DOCUMENTATION | 3 |
| ETI 2041 | MEDICAL DEVICE DESIGN AND MANUFACTURING | 3 |
| ETI 2171 | QUALITY AUDITING FOR MEDICAL DEVICES | 3 |
TOTAL CERTIFICATE HOURS |
15 |
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C&I 6/24/08 ~ BOT 8/19/08 |
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