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Regulation, Clinical and Software for Medical Devices

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November 5 - 7, 2024
The Royal Sonesta Minneapolis DowntownMinneapolis, Minnesota

Mira Leiwant
Vice President, Regulatory Affairs, Quality, and Clinical Affairs at Anika Therapeutics, Inc.
Speaker

Profile

Mira Leiwant currently serves as VP of Regulatory Affairs, Quality and Clinical Affairs for Anika Therapeutics, a global joint preservation company that creates and delivers meaningful advancements in early intervention orthopedic care. Her responsibilities include strategic planning and assessment for all Anika’s products, and developing systems to meet ever-changing global regulatory demands. She has over 20 years’ experience in the medical device industry, spanning several functional areas from R&D to Quality Assurance and Regulatory Affairs, for products in the therapeutic areas of cardiology, wound care, regenerative medicine, and oncology. She earned both Bachelor’s and Master’s degrees in Mechanical Engineering from Cornell University, and holds a Regulatory Affairs Certification.


Agenda Sessions

  • Inviting Innovation: Encouraging Innovative Devices back to Market

    8:20am
  • Breaking Down the US System: Regulating Devices under the FDA

    9:05am
  • Ask the Experts: Medical Devices

    4:40pm