Regulatory Affairs of Medical Devices


Date: 24, 25 October 2018
Location: Crowne Plaza Tel Aviv
General Information
Duration: 2 - Day Course
Hours: 9:00 – 17:00
Price: 3,900 NIS+VAT
Credit Points: 2
SKU: 18053
Course Language: Hebrew
About the Course
This course focuses on medical device regulatory affairs topics in the following countries: USA, Europe, Canada, Australia, Japan, and Israel.
The course covers the legislation governing development, manufacture and commercial distribution of medical devices; classification and compliance; requirements for pre-clinical and clinical testing; processes for obtaining marketing clearance\approval; etc.
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 regulatory affairs in medical device companies that are new to the profession or are interested in expanding their knowledge.
Regulatory Affairs of Medical Devices
Benefits to the Participants
Participants in this course will:
  • Get an overview of global regulatory requirements for bringing a new medical device to the market 
  • Gain knowledge of the requirements and regulatory processes in major regions
  • Study from experience of others by learning and discussing case studies
  • Have an opportunity to share their regulatory challenges and experiences with colleagues
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Issues to be covered
  • Regulatory Affairs – the Profession and Terminology
  • USA Regulatory Affairs
  • EU Regulatory Affairs
  • Canada Regulatory Affairs
  • Australia Regulatory Affairs
  • Japan Regulatory Affairs
  • Israel Regulatory Affairs
  • Lessons Learned from the Mistakes of Others – Case Studies
About The Lecturer

Ms. Shoshana Friedman

Shoshana (Shosh) Friedman is the President and CEO of ProMedoss, Inc. Shosh has more than 20 years of experience in the fields of regulatory affairs, clinical trials, and quality assurance of medical devices and biotechnology.
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