How to Bring the FDA in Early during Medical Device Development with DeviceTalks Tuesdays | Sagentia Innovation

How to Bring the FDA in Early during Medical Device Development with DeviceTalks Tuesdays

Date: 21 September 2021

Time: 4:00PM EDT (9:00PM BST)

Location: Virtual

Rob Morgan, Laurie Clarke, and Eduardo von Ristow have a round table discussion about how to integrate FDA regulatory strategy and a well-crafted value proposition into medical device development and the benefits of this one-team approach. The event will focus on real issues faced by those involved in developing, assuring compliance and quality, investing, and marketing medical devices.

Tom Salemi will ask the table questions on how to navigate the 510(k), de novo, and PMA routes to market, translate concepts into products and maximise their chance of success by better understanding different stakeholders' needs, technology feasibility and commercial viability.  They will share real-world examples of design, approval, and value-based product differentiation challenges, as well as practical tips for overcoming them based on their experiences with a wide range of medical devices.

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