One of the most relevant and talked about topics in the medtech industry in recent years is related to Software as a Medical Device (SaMD), and these devices present particular challenges as technology advancements often outpace global regulations and other industry guidance. As a result, device Sponsors are required to have earlier and more frequent interactions with regulatory agencies in an effort to align on regulatory pathways, clinical data analyses and more.
When factoring this in with additional Quality System requirements and new guidance and/or industry information, Sponsors can begin to feel overwhelmed with nowhere to start. Today’s regulatory affairs professionals must not only have a solid foundation surrounding SaMD regulations, but also an in-depth understanding of how these requirements link to quality and clinical data requirements through the full product development continuum to achieve efficient, cost-effective outcomes.
This webcast will focus on best practices and proven strategies to address challenges presented by today’s shifting SaMD regulatory environment, and discuss how early integration of regulatory, quality and clinical data planning are the keys to commercial success.
Upon conclusion of the program, participants will:
- Understand how to better navigate regulatory requirements and recommendations for SaMD products
- Know how to build effective Quality Systems that adhere to SaMD requirements through the Total Product Development Lifecycle
- Learn best practices for discussions with the FDA regarding SaMD products, including key information to present during these interactions
- Understand SaMD clinical evaluations at a high-level
- Learn how to handle clinical data and how to position data in support of regulatory submissions
- Understand how post-launch support surrounding software maintenance, re-validation, decommission and disposal of the Health Software products is helpful
- Realize how leveraging best practices linking regulatory, quality and clinical data strategies can save costs throughout the development process and accelerate commercialization
To register for this on-demand webinar, please fill out the following form.