Why Should You Attend:
The 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.
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. Also to be covered, will be the EU medical device classification process compared to the US process.
Areas Covered in the Webinar:
Who Will Benefit:
This webinar is applicable to the Medical Device industry. Titles includes:
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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