Getting FDA Clearance/Approval for Medical DevicesWhat, When and How?

 

Date: 4 November 2019
Location: Bioforum, Golda Meir 3, Ness Ziona.
General Information
Duration: 1 - Day Course
Hours: 09:00 – 17:00
Price: 1,950 NIS+VAT
Credit Points: 2
SKU: 19831
Course Language: Hebrew
About the Course
The thriving medical device industry has brought with it a bombardment of regulations and requirements which continue to increase as the industry itself develops. The main challenge for industry is no longer to merely identify the applicable regulations but to identify the means by which to apply the applicable regulatory framework in order to successfully gain market entry and remain in the market. This course offers participants exposure to the core concepts of FDA medical device regulatory framework and provides tools for its actual application in real world scenarios. Participants will be introduced to US FDA laws and regulations, clinical trial regulations, guidance documents, submission requirements, and more.
The course is provided in an open atmosphere and the participants are given opportunities for questions and discussion related to the topics.
Who should attend
This course is intended for individuals with responsibility for FDA regulatory affairs in medical device companies that are new to the profession or are interested in expanding their knowledge
Getting FDA Clearance/Approval for Medical DevicesWhat, When and How?
Benefits to the Participants
Participants in this course will:
  • Get an overview of FDA regulatory framework for bringing a new medical device to the market  
  • Gain knowledge of the requirements and regulatory processes
  • Study from experience of others by learning and discussing case studies
  • Have an opportunity to share their regulatory challenges and experiences with colleagues
Contact us
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Issues to be covered
  • Legislation governing development, manufacture and commercial distribution of medical devices
  • Classification of medical devices
  • Requirements for pre-clinical and clinical testing
  • Processes for communicating with FDA
  • Submissions for obtaining marketing clearance\approval
  • FDA enforcement methods
  • Specific compliance issues related to medical devices
About The Lecturer

Ms. Bosmat Friedman

Bosmat Friedman is the Head of Clinical & Regulatory Services of ProMedoss. She has been working as a regulatory consultant since 2007 initially as a consultant in Push-Med and subsequently as the CEO of MJ RAC.
For more information please click here


Ms. Shoshana Friedman

Shoshana (Shosh) Friedman is the President and CEO of ProMedoss, Inc. Shosh has more than 28 years of experience in the fields of regulatory affairs, clinical trials, and quality assurance of medical devices and biotechnology.
For more information please click here


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