Medical Device Design Controls

Certificate Short Course

There are more than 6500 medical device companies in the United States. These large and small companies produce a wide range of products, from bandages to MRI machines. Each of these companies must follow design control regulations from the Food and Drug Administration (FDA) and the International Organization for Standardization (ISO). Participants in this course will gain an understanding of the regulations and how they work to ensure that the devices meet the end users’ needs and meet regulatory requirements. In addition, participants will learn the elements of the design control process, documentation, and will gain an appreciation of the role that design controls have on pre- and post-market device development.
Participants in this course will learn:

• The importance of the FDA and regulating medical devices
• FDA regulations for design control
• Good documentation practices
• The role of design controls in pre- and post-market development
Medical Device Design Controls is an elective course in the Document Management, Operations Management, and Quality Management certificate pathways.
This course is available online, and can be taken anytime, anywhere.


Fee $125.00
Course Type Online
Instructor Wayner Williams
Duration 2.5 hours
Cert. Pathway(s) Document Management
Operations Management
Quality Management