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