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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.
You owe it to your organization — and yourself — to tune in to this presentation.
Bonus Supplementary Materials:
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:
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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