Get Pre-Certified: Your Software as a Medical Device - Webinar Recording/Transcript

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Get Pre-Certified: Your Software as a Medical Device

Bring yoursoftware as a medical device (SaMD) product to market faster with the Software Precertification Program. The pre-cert pathway regulatory model expedites pre-market approval while assessing the safety and effectiveness of your software technologies.

Noted Washington lawyer Michael M. Gaba Esq. will outline strategies you may be able to take advantage of immediately. You won’t want to miss a word of his explanation on the benefits of pre-cert.

Lessons:

  • Understand how to streamline your premarket review
  • Leverage information and data obtained during pre-cert
  • Learn how to establish a more modern and tailored approach toward software integration

You owe it to your organization — and yourself — to tune in to this presentation.

Bonus Supplementary Materials:

  • FDA’s Digital Health Innovation Action Plan
  • Software Precertification Program: 2019 Test Plan
  • IMDRF “Software as Medical Device: Application of Quality Management System.”

This presentation will be of interest to device and drug makers, software developers, and firms now using software in clinical trials or in patient applications and uncertain whether the software qualifies as a SaMD (software as medical device). Specific job titles include:

  • Executive suite
  • Software engineers/developers
  • Regulatory affairs/compliance
  • Quality affairs
  • Validation professionals
  • Clinical trial executives
  • Strategic planning
  • Marketing/sales
  • Legal counsel

Michael M. Gaba Esq., Practice Vice Chair, Polsinelli LLP, provides device and biotech clients with strategic counsel on FDA regulation and Medicare reimbursement, plus efforts to influence public policy. Working with legal and business teams, his goal is to bring companies to market then help them stay there.