MATTER Workshop: Understanding Medical Device Regulations in the U.S.

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MATTER Workshop: Understanding Medical Device Regulations in the U.S.

MATTER members and partners: use your discount code for 100% off registration price. If you don't know your code, email info@matter.health.

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Online

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About this event

  • 1 hour 30 minutes
  • Mobile eTicket

To get a medical device to market in the United States, you need to understand and implement a myriad of regulations based on the classification of your device. This course presents an introduction to the regulation of medical devices in the U.S.

Join this workshop to learn how to:

  • Learn the history of medical device regulation in the U.S.
  • Understand risk-based device classification in the U.S.
  • Learn about all the medical device regulations in the U.S. and know where to find them.
  • Know how to determine which regulations apply to your product.
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ABOUT THE FACULTY:

Deborah Baker-Janis is a Senior Consultant in the Medical Device Consulting Practice at NSF. Deborah joined NSF in 2013 after working in the medical device industry for over 10 years, including in both regulatory affairs and product development. Her experience includes domestic and international regulatory strategies and submissions, design control documentation development, Quality Management System and regulatory affairs procedure development and remediation and training development and execution. Ms. Baker -Janis has worked for a wide range of companies from small start-up organizations to Fortune 500 companies and supported the development and commercialization of a variety of Class II and III products including cardiovascular devices, general and plastic surgery devices, gastroenterology devices and general hospital devices.

Samuel Brown is a Medical Devices Consultant for NSF Health Sciences serving commercial clients in the healthcare sector, with a focus on managing challenging issues in regulatory, public policy and litigation forums. Sam’s experience includes development, consultation and publication of US regulatory submissions including Q-submission requests, premarket notifications (510(k)) and premarket approvals (PMA); development and consultation on regulatory strategies and gap assessments for Class II and Class III medical devices; and quality management system assessment and auditing against US FDA, EU MDR/IVDR and MDSAP-participating country requirements. He joined NSF Health Sciences in 2017 and holds a Bachelor of Science and Master of Science in Biomedical Engineering from the University of Florida.

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This workshop is part of our Life Sciences series.

Workshops in this series are designed to help life sciences entrepreneurs tackle challenges across the commercialization journey, from selecting a contract research organization for preclinical studies through structuring intellectual property, setting up a quality management system and preparing assets for acquisition.