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


Paul Upham
Head of Smart Devices
Roche / Genentech
Kal Patel, MD
CEO & Co-Founder
Jamie Burgess
VP, Marketing
Please enter your details to listen to our 50-minute webinar.