Classifying Medical Devices Made Easy

Duration 60 Mins
Webinar ID IQW15C8105

  • Medical Device classifications – an introduction
  • 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?
  • EU medical device classifications

Overview of the webinar

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. This workshop will cover the steps for classifying a medical device using the FDA Product Classification Database. 
Key definitions related to classifying medical devices will be provided to include intended use, indications for use, risk and general and special controls.

Who should attend?

  • Any professional involved in the design, development, and manufacturer of medical devices
  • Engineers 
  • Scientists 
  • Regulatory Personnel 
  • Quality Assurance Personnel

Why should you attend?

The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device.
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.
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.

Faculty - Mr.Charles H. Paul

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence. He is a regular presenter of webinars and on-site seminars in a variety of related subjects from documentation development to establishing compliant preventive maintenance systems.


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