FDA UpdatesNew Requirements, Trends and Guidelines

Conducted by: Ms. Shoshana Friedman
SKU: 20832
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Stay current on the ever-changing medical device regulatory environment with this 2 half days course offering practical guidance on navigating recent changes in FDA requirements, trends and guidelines. This course offers participants updates on a variety of topics like
  • Emergency Use Authorization (EUA)
  • Medical Device Development Tools (MDDT)
  • CDRH's Innovation Initiative
  • Digital Health
  • CDRH’s Strategic Prioritie
  • Technical Amendments to...Continue reading

Stay current on the ever-changing medical device regulatory environment with this 2 half days course offering practical guidance on navigating recent changes in FDA requirements, trends and guidelines.
This course offers participants updates on a variety of topics like

  • Emergency Use Authorization (EUA)
  • Medical Device Development Tools (MDDT)
  • CDRH’s Innovation Initiative
  • Digital Health
  • CDRH’s Strategic Prioritie
  • Technical Amendments to Medical Device Regulations
  • CDRH New Programs (e.g., Health of Women Program)
  • Medical Device Innovation Consortium (MDIC)
  • New guidance documents

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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Dates: 
  • 16/09/2020
  • 17/09/2020
Course location: Zoom Course
Duration: 2 half-day Course (Evening)
Hours: 13:00 - 16:30
Credits: 1
Course Language: עברית

Course price: 1,800 NIS + VAT
Early registration is Closed
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Issues to be covered

  • Updates on legislation affecting medical devices
  • Recent FDA initiatives related to medical devices
  • Trends in FDA activities related to medical devices
  • New guidance documents affecting medical devices

Who should attend

This course is intended for individuals with responsibility for FDA regulatory affairs in medical device companies that are interested in updating their knowledge.

Benefits to the Participants

Participants in this course will:

  • Get an overview of changes in FDA jurisdiction over medical devices
  • Gain understanding of trends in FDA regulatory framework of medical devices
  • Strengthen knowledge of FDA requirements
  • 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

Shoshana Friedman
Shoshana (Shosh) Friedman is the President and CEO of ProMedoss,
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