Classifying Medical Devices - US and EU

The Medical Device Classification webinar explains the classification system in US and the EU.

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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.

Learning Objectives:
  • List and describe the three US FDA Medical Device Classifications
  • Explain how a medical device classification is made
  • Explain/define medical device exemptions
  • Explain when the medical device exemptions apply
  • Explain General and Special Controls
  • Explain when General and Special Controls apply
  • Explain reclassification
  • Define the EU medical device classifications and those classifications are determined
Areas Covered in the Webinar:
  • Medical device definitions
  • US Medical device classifications
  • EU Medical Device Classifications
  • Key Terms and definitions
  • Explain General and Special Controls and how they are applied
  • Types of medical devices
  • How US Medical devices are classified
  • How EU Medical devices are classified
  • List and describe the applicable US and EU regulations for medical device classification
Who Will Benefit:

This webinar is applicable to the Medical Device industry. Titles includes:

  • Audit and Compliance Personnel
  • Regulatory Professionals
  • Quality Professionals
  • Risk Managers
  • Design Engineers
  • Research and Development Engineers
  • VP, Directors and Managers of medical device design functions
  • Medical device marketing and sales personnel
Instructor Profile:
Charles H. Paul Charles H. Paul

President, C H Paul Consulting Inc

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.

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email call +1-888-771-6965 (Toll Free).

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