Are you and your team seeking guidance to stay in the know when it comes to new and updated FDA requirements related to medical devices, especially during the ongoing pandemic?
Listen to this Greenlight Guru podcast episode as Mr. Regulatory, David Pudwill, shares his predictions on potential policy changes or updates we may begin to see from FDA, as influenced by the Emergency Use Authorization (EUA) response to address the current health crisis caused by the COVID-19 pandemic.
In this Global Medical Device Podcast episode, Jon Speer, Greenlight Guru's founder and VP of QA/RA, talks to David Pudwill, senior director of regulatory affairs at ConvaTec and industry thought leader, who has been coined the name “Mr. Regulatory.”
Posted October 7, 2020
In this inaugural episode of the Mr. Regulatory “Guest Speaker Sessions” series, David discusses FDA’s evolving regulatory guidance and requirements for remote patient monitoring devices in light of the COVID-19 public health emergency, during AcKnowledge Regulatory Strategies’ Virtual Regulatory Alliance Forum (RegAF) 2020 conference, held August 17-19, 2020. Includes Allison Komiyama, PhD, of AcKRS, & Stayce Beck, PhD, MPH, VP Clinical & Strategic Partnerships, Dexcom.
The views and opinions expressed on this site and in all videos are those of the authors, speakers, and guests, and do not necessarily reflect the official policy or position of any company, FDA, or any other entity.
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