MDTIOC.ORG - Medical Device Certificate Program

Training: Courses and Certificate Programs

Medical Device Certificate Program

Course Schedule

MDTIOC was created in 2006 through the funding of an Economic & Workforce Development Grant. We are committed to training new employees to prepare for a career in the medical device industry. Workers who are employed in the industry can also take advantage of this training at no cost.

MDTIOC has partnered with key industry experts to provide new and existing workers with a Medical Device Certificate Program. This program enables participants to work with medical device industry experts regarding the most prevalent trends in the industry. The certificate consists of the following 8-hour courses. Completion of all 32-hours is necessary for certificate completion.

Introduction to the Medical Device Industry (8 hour Credit)

Whether you currently work in the medical device industry or you are planning a new career, this course is designed to give you an introduction and overview of a multi-billion dollar industry that is growing quickly.

Quality System/ISO 13485:2003 (8 hour Credit)

Training is designed to support personnel and assist them in ISO Quality Program. This workshop will assist you in learning the management and compliance of quality excellence programs.

Overview of FDA's Medical Device Regulations (8 hour Credit)

The course provides a base line understanding of the U.S. Food & Drug Administration (FDA) regulation and compliance for medical devices. The coverage of material is specific to medical device manufacturing. Topics include the FDA statutes and regulations, the organization of the FDA, the medical device approval process, laboratory and clinical studies, the introduction to the Quality System Regulations (QSR's), the FDA inspection process, and international regulation.

Fundamentals of GMP and QSR (8 hour Credit)

This course is designed for anyone entering the FDA regulated medical device industry and whose job responsibility requires a comprehensive understanding of the basic concepts of Good Manufacturing Practice and Quality System Regulations.

All classes are held on the North Orange County Community College's School of Continuing Education located at 1830 W. Romneya Dr. Anaheim, CA 92801

Enrollment Information

For 2007-08, this training will be State-subsidized for all participants. To sign up for one or all of the workshops, please call the Program Director at (714) 808-4575.