Medical Device Classifications

When designing and developing medical devices it is essential to properly classify your device early on in the process to prevent costly and cumbersome regulatory issues and added or unnecessary work later in the design and development process. The determination process, how you apply the process to your device, is complex and requires several levels of analysis to make the proper device classification.

This workshop will provide insight into the classification process as regulated by the FDA and will provide a methodology to assist in properly making your classifications.

Areas Covered in the Session :

• Medical Device classifications – an Overview
• Does the product emit radiation?
• Determining if your product is a medical device
• What are the medical device classification panels?
• What are exemptions and when do they apply – Class I/II?
• What is the product code classification database and how is it used?
• What is reclassification?

Who Should Attend:

• Quality Engineers
• Project Managers
• Regulatory Affairs Department
• Product Design and Development Departments

Course Director: CHARLES H. PAUL ‎

Charles Paul is an instructional designer and management consultant with over 30 years experience providing training and consulting services to regulated industries. He has installed quality systems and designed and developed GMP and operational documentation and training programs for foods and beverage, pharmaceuticals, biotech, cosmetics, and consumer product OTC industries.