Description: AI and digital transformation are revolutionizing the way Medtech companies and regulators bring new medical devices to market efficiently and cost-effectively.
They will share how MedTech leaders can adapt to digital changes at regulatory bodies like the FDA and Health Canada, highlighting the eSTAR program.
They will discuss how to use AI and digital tools to streamline regulatory processes, speed up market access, and ensure compliance through the entire product lifecycle.
The session will cover specific strategies for managing regulatory submissions and leveraging technology for better regulatory intelligence and management of complex devices, including AI and software-based medical devices."
Learning Objectives:
Gain strategic insights into how digital transformation within regulatory agencies affects the MedTech industry.
Learn about the risks of not adapting to the digital advancements in the MedTech landscape.
Understand how embracing digital transformation in regulatory and compliance activities can offer MedTech companies a strategic advantage by increasing efficiency, reducing costs, and improving patient access to medical devices.
Explore real-world applications of AI and cloud solutions in regulatory affairs, covering the entire product lifecycle from submissions to post-market changes, along with a framework for achieving regulatory excellence.
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