How to Launch Regulated Software as a Medical Device in 6 Months’ Time
Roche executive shares how they launched a CE-marked dosing calculator to treat Hemophilia A
In a race to enhance and personalize their therapies, biopharma and medtech companies are focusing more on Software as a Medical Device, or SaMD.
Many of our customers ask us about the end-to-end process of developing and maintaining SaMD. Specifically, we’re asked about how to select an underlying digital health platform to host SaMDs, how to develop a SaMD, and how to launch and maintain SaMD in a compliant way.
Given the interest in the topic, we asked Paul Upham, Head of Smart Devices at Roche/Genentech to share how Roche launched a regulated SaMD dosing calculator for treating Hemophilia A in less than 6 months’ time.
Listen to our webinar discussion with Roche to learn:
- How SaMD can alleviate the burden on our strained healthcare systems amidst the global COVID-19 pandemic
- How Roche evaluated digital health technology partners and why they selected BrightInsight
- How to successfully develop and launch regulated SaMD
- What goes into maintaining regulated SaMD from a regulatory, privacy and security standpoint across regions
Biopharma and R&D
The headline tells us what you're offering, and the header closes the deal. How to Launch Regulated Software as a Medical Device in 6 Months Time How to Launch Regulated Software as a Medical Device in 6 Months Time.