Medical Device Manufacturing: Processes & Practices
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. A core knowledge and skills certificate will be awarded upon the successful completion. This training is appropriate for those new to the industry, transitioning from a related discipline or professionals wanting refresher courses.
Schedule
Courses are offered on flexible schedules to accommodate your schedule. See the courses tab for more detail.
Career Opportunities
- Quality Assurance
- Quality Control
- Quality Control Inspector
- Quality Inspectors
- Quality Control Technicians
This program has been approved for STIT funding (50% discount for individuals) while funds are available
For Individual Job Seekers
The Utah Legislature provides Short-Term Intensive Training (STIT) funds for Utah State residents who enroll in specific non-credit, short-term training courses. These funds cover 50% of the course cost and are available until depleted. At that point, the course cost will return to the regular cost. STIT funding is for individual job seekers. For employers interested in funding support, please see information about Custom Fit.
For Employers
Using funds provided by the Utah State Legislature, Custom Fit provides short-term, non-credit training designed to grow, train, and retain an efficient and productive workforce. For-profit companies can use these funds to share the cost of incumbent worker training. Apply for Custom Fit funds to determine eligibility.
Investment
Participants who successfully complete the 84 hours of training can earn the Medical Device Processes and Practices Certificate.
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 product life cycle from conception to market approval and distribution.
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 successful careers in the medical device and bioscience industry.
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 regulations and an overview of equivalent international regulations will be covered.
Master the competencies related to the regulation of medical device quality systems. In particular, students will be able to describe regulations 21 CFR 820 ISO13485 and explain the consequence of noncompliance to the company and its employees. Students will demonstrate the ability to assess situations of noncompliance and analyze the effects on the company. This course introduces the concept of a quality system, system structure, and its relevance to the medical device and life science industry. Individuals will understand proper setup and operation of a quality system, including the FDA-required Good Manufacturing Practices (GMP).
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 quality control concepts will be supplemented by the standards and tools used by quality control technicians for inspection, calibration, and proper follow up within the requirements of current Good Manufacturing Practices (cGMP). Mastery of this knowledge is key to successful careers in quality control, and the context is specifically focused on medical device quality control. This course requires students to work self paced online participating in discussions, completing weekly course requirements. An optional one hour weekly Zoom meeting with the instructor and students will give students the opportunity to collaborate and ask any questions as the course progresses. In addition, students will apply their computer skills, particularly with Microsoft Word and Microsoft Excel to effectively use quality tools and descriptive writing skills.
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 standards and regulations from an auditor’s perspective. Learn the audit program structure, auditing planning, audit performance, audit reporting and action plans. Techniques and tools for conducting a successful quality audit. This course is designed for someone who may be new to auditing in the Medical Device industry or participating as a team member (and/or) interact with audits.
Short Term Intensive Training (STIT) funding is available for this course. Contact Kay Carter at kay.carter@slcc.edu or 801-957-5373 to determine eligibility.
Participants who successfully complete the 96 hours of training can earn the Medical Device Core Knowledge and Skills Certificate. The following foundational courses must be completed with a passing grade:
- WTMD 0910 - Introduction to Medical Device Industry
- WTMD 0920 - Basic Manufacturing Skills
- WTMD 0930 - Introduction to FDA Regulations
- WTMD 0940 - Introduction to Quality Systems
Participants completing individual courses to meet FDA compliance training requirements may request letters of completion for personnel files.
These courses are noncredit, however, there is a credit pathway that has been established. After completion of both WTMD 0910 and WTMD 0920, students can receive credit for SLCC BTEC 1025 (3 credits). After completion of both WTMD 0930 and 0940, students can receive credit for SLCC BTEC 2035 (2 credits).
Visit the website for the National Center for the Biotechnology Workforce