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Medical Device: Meeting Development and Global Regulatory Challenges

 
  February 12, 2015  
     
 
CfPA-The Center for Professional Advancement, New Brunswick, NJ
August 24-25, 2015


Who Should Attend?
In a global environment that has dramatically changed, the clearance and approval of medical devices has become a challenge. Companies who plan on developing and marketing their medical devices both in the USA and globally will profit from taking this comprehensive and efficient course. This course will answer many of the questions regarding medical device development and meeting the ever changing regulatory and marketing challenges. Personal in the following positions will gain insight and knowledge in this area and include:

  • Manufacturing
  • Regulatory
  • Medical monitors
  • Q/C and Q/A
  • Protocol Development

Course Description
This course is designed to give a comprehensive understanding of medical device development and global regulatory requirements. It will give a thorough review of ISO 13485 as well as the most recent EU directives. Emphasis will be placed on development, risk management, regulatory and marketing of medical devices. Participant discussion and problem solving will be strongly encouraged.

Maximize Your Learning!
Attend this course and its Companion Course:
Adaptive Research: A Path to Efficacy and Efficiency
August 26-27, 2015 • New Brunswick, NJ • Course ID #2656
 
 
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
Bart Chapman MD MBA FAAO

Bart Chapman, MD MBA FAAO, a board certified physician with over 30 successful years in the medical device industry, has been involved in IDEs, 510K clearance and PMAs and directing clinical trials through all phases of development for medical devices.

His role has varied from developing Phase I-IV protocols and implementing them to overseeing strategic marketing and distribution of numerous medical devices on an international basis and in accordance with global regulatory standards.

He has secured sophisticated SABs for medical device development and created strategic protocols for meeting ISO 13485 standards as well as EU directives. As a physician investigator, Doctor Chapman has been intricately involved in both medical device therapeutics as well as diagnostic devices. As a pharmacovigilence medical director, he has been responsible for safety measurements of medical devices both pre and post clearance and in meeting with CDRH panels.

Dr. Chapman brings a wealth of knowledge and experience in the medical device arena both from a regulatory point of view as well as a clinician.

 


 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
 
   
 
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