Innovative Medical Device Programs

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Innovative Medical Device ProgramsIncluding the Breakthrough Device Designation (BDD) and the Safer Technologies Program (STeP)

Expert Lecturer: Ms. Shoshana Friedman

SKU: 241122W

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The 21st Century Cures Act was signed into law on December 13, 2016. The Act was designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently.
Subsequently, over the past few years, FDA has established and further refined two programs intended to expedite the regulatory submission process for innovative medical devices, the Breakthrough Device Designation (BDD) and the Safer Technologies Program (STeP).Both programs offer beneficial and potentially time saving opportunities for medical device companies.
In this session we will provide an overview of the benefits of these programs and the criteria that must be met in order to receive a designation.
Additionally, we will share some of the insights gained from personal experiences utilizing these programs.

Date: 20 February, 2024

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Course location: Zoom Course

Duration: 1-Day Course

Hours: 18:00 - 19:00

Credits: 0

Course Language: עברית

Course price: Free of charge

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About The Lecturer

Shoshana Friedman

Shoshana (Shosh) Friedman is Founder and Managing Director of ProMedoss,