Get Pre-Certified
Your Software as a Medical Device

Thursday, Aug. 1, 2019 · 1:30 p.m. - 3:00 p.m. EDT

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.


  • 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 timely webinar. Join us by registering today.

Who Will Benefit

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

Webinar plus USB Audio Recording/Transcript
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Webinar only
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24/7 Encore plus USB Audio Recording/Transcript
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24/7 Encore Presentation
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USB Audio Recording/Transcript
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BonusSupplementary Materials:

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


Meet Your Presenter

Michael M. Gaba Esq.

Practice Vice Chair
Polsinelli LLP

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.

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