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Save the dateJune 22, 20213 PM - 4:30 PM (GMT+2)
Organizer
Organizer
Contact Person: David Dolhomut
Event Details
Event Details

The American Investor Desk and POLMED cordially invite you to participate in a free educational meeting called "Establishing your medical devices through the FDA in the USA" on June 22, 2021, from 3:00-4:30 p.m. Our speaker will be Rick Proctor, Managing Partner at BreakThrough Life Science Consulting; and Jeff L. Smith, President & CEO at The Braveheart Group, Inc.


The event is aimed at companies interested in the medical device sectoral branch in the United States by highlighting the navigation process of the most challenging medical devices/areas on the U.S. marketplace (i.e., software, apps, LDTs).


During the meeting, we would like to familiarize you with a brief overview of traditional U.S. pathways, software as a medical device (SaMD), mobile medical applications, laboratory-developed tests (LDTs), quality systems, intellectual property issues, government contracting, and promotional claims and practices.


Detailed agenda:


Brief Overview of Traditional U.S. Pathways

  • Classes I, II, II
  • De Novo
  • Examples of devices for each category


Software as a Medical Device (SaMD)

  • Definition statement
  • Risk characterization
  • Regulatory pathway
  • Machine learning / artificial intelligence
  • Examples


Mobile Medical Applications

  • What are mobile medical apps?
  • Device software functions that are the focus of FDA oversight
  • Software functions for which the FDA intends to exercise "enforcement discretion"


Laboratory Developed Tests (LDTs)

  • LDTs defined
  • Risk-based classification
  • The impact of 23andme
  • Examples


Quality Systems

  • FDA vs ISO 13485


Intellectual Property Issues

  • Software
  • Artificial intelligence


Government Contracting

  • Registration requirements
  • Access to contracts


Promotional Claims and Practices

  • Impact on the regulatory pathway


Q&A Session

Speakers
Speakers
  • Rick Proctor (Managing Partner at Breakthrough Life Science Consulting)

    Rick Proctor

    Managing Partner at Breakthrough Life Science Consulting

  • Jeff Smith (President & CEO of Braveheart Group)

    Jeff Smith

    President & CEO of Braveheart Group

Sponsors and Partners
Sponsors and Partners