MDTIOC.ORG - Industry Resources

Industry Services

The U.S. medical device industry is growing quickly and responding to global competitors in the process. According to the Advanced Medical technology Association (AdvaMed) American production of medical devices and diagnostics reached an estimated $77 billion in 2002.

Additionally, remaining compliant and current with FDA regulations has remained a critical effort for most medical device and diagnostic companies.

In response to these and other industry trends, MDTIOC has become a local resource for specialized training to help your business grow. Through Economic & Workforce Development funding courses are available to companies at no cost during the grant period. We provide on-site and off-site training to Orange County medical device and diagnostic companies. Both introductory and advance courses are available. You will select courses of interest for your employees and customize training modules for your company. In addition to the key topics below, courses are created and customized based on company needs.

Key Training Topics (Click here to view our Course Schedule.)

Clean-Room Techniques and Procedures
Device manufacturing
European Union Regulations
General Principles of Software Design for Medical Devices
Introduction of New Medical Device Products
Product Design
Regulatory Affairs
Quality Systems Regulations and Assurance
Quality Auditing for Medical Devices

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 four 8-hour courses.

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.