New
Free webimar

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

Conducted by: Ms. Shoshana Friedman
SKU: 241122W
Print version

Share a colleague:

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...Continue reading

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.

Close
Date:  20 February, 2024

מתעניינים? לחצו כאן

    Course location: Zoom Course
    Duration: 1-Day Course
    Hours: 18:00 - 19:00
    Credits: 0
    Course Language: עברית

    Course price: Free of charge

    Have a question? We got all the answers

    About The Lecturer

    Shoshana Friedman
    Shoshana (Shosh) Friedman is Founder and Managing Director of ProMedoss,
    Read more
    תחזוקת מערכת האיכות בזמן מלחמה QMS

    Leave a Reply



      [anr_nocaptcha g-recaptcha-response]