Explore the rapidly evolving medical device regulatory landscape and uncover the innovative strategies that companies are implementing to support smarter, faster approvals for innovative technologies. Don’t just get familiar with the trends impacting the industry—get ahead of them. Join two of PAREXEL’s ex-FDA subject matter experts for an exclusive program where you’ll stay up to date on regulatory advances, learn to implement new concepts, and much more.
Disruptive technologies, including artificial intelligence, additive manufacturing and digital biomarkers, have altered clinical practice and patient access paradigms in fundamental ways. Coinciding with correlating industry trends of patient centricity, customization, and ease of access, groundbreaking evolution in the medical device arena is fully underway. The FDA has recognized the challenge of the shifting marketplace and has taken concrete steps to adapt the medical device regulatory framework to facilitate patient access to innovative products in the United State first in the world. Partnering with JLABS, PAREXEL’s subject matter experts will examine recent and ongoing changes in the regulatory ecosystem for medical devices and combination products and discuss methods to optimize development and regulatory strategies to streamline regulatory approvals and achieve commercial success.
Topics covered will include the following:
• Strategies for Regulatory and Commercial Success
• Accelerated Pathways
• Modernization of FDA’s 510(k) Program
• Early Stage Clinical Trials for Medical Devices
• Updated Regulatory Framework for Digital Health
• Optimal Strategies for Successful FDA Meetings