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Webinar on Medical Device Classifications

 
  April 28, 2016  
     
 


Compliance Trainings, Online
2016-05-06


Description :

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 Will Benefit:

Quality Engineers

Project Managers

Regulatory Affairs Department

 

Product Design and Development Departments

 
 
Organized by: Compliance Trainings
Invited Speakers:

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.

 
Deadline for Abstracts: 2016-05-06
 
Registration:

For more information about this event please visit

 

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1775

E-mail: suzzane.d@compliancetrainings.com
 
   
 
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