Medical and Regulatory Affairs

The Regulatory Landscape of Software as a Medical Device

So much of the medical world is about data, and as healthcare data continues to play an increasing role in the “big data” landscape, the challenge is figuring out how to use it properly within the healthcare ecosystem. A new class of medical software known as Software as a Medical Device (SaMD) is offering innovative ways to capture, optimize and analyze healthcare data with the goal of improving health by utilizing analytics to manage and optimize health outcomes. However, this rich field of technology is evolving more quickly than regulators can keep up.

The challenge is when a software is designated as SaMD, a string of regulatory requirements come into play, creating a maze of potential pathways and product development implications. In this webinar, the panelists will define what is considered a SaMD and explore key strategies to bring it to market successfully through regulatory strategy, clinical impact and considerations for patient engagement and participation.

Presented by:

Nach Davé, RPh., MSc, Vice President, Development Strategy, Premier Research

Vicki Gashwiler, Executive Director, Specialty Programs, Premier Research

To watch the full webinar submit the form on this page.