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

Conducted by: Ms. Bosmat Friedman, Ms. Shoshana Friedman
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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...Continue reading

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.

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Date:  4 November, 2019
Course location: Kfar Maccabiah, Ramat Gan
Duration: 1-Day Course
Hours: 09:00 - 17:00
Credits: 1
Course Language: עברית

Course price: ₪3,900 Including VAT
Early registration is Closed
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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

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

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

About The Lecturer

Bosmat Friedman
Bosmat Friedman is the Head of Clinical & Regulatory Services
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Shoshana Friedman
Shoshana (Shosh) Friedman is the President and CEO of ProMedoss,
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