Medical Device Manufacturing: Processes & Practices
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.
Section List
WTMD 0910-001
WTMD 0910-002
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.
Section List
WTMD 0920-002
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.
Section List
WTMD 0930-002
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).
Section List
WTMD 0940-001
WTMD 0940-002
WTMD 0940-003
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.
Section List
WTMD 0950-001
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.
Section List
WTMD 0960-001
For more information contact Kay Carter at kay.carter@slcc.edu or 801-957-5373.
Participants who successfully complete the 84 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