This is the audio-only version of RQM+ Live! #1, originally recorded April 17th, 2020.
The medical device industry’s reliance on China for suppliers, manufacturing sites, and finished medical devices is widespread and well understood. In 2019, the U.S. President leveraged the “International Emergency Economic Powers Act (IEEPA)” in an effort to urge United States companies to begin searching for production alternatives outside of China. The act authorizes the President to regulate foreign economic transactions when a national emergency is declared to manage any unusual and extraordinary foreign source threat to the U.S.
Fast forward to 2020 and we now know that COVID-19 is magnifying the vulnerability of the U.S. and other countries using China for the production of medical devices. Few could predict that we would be faced with the current struggle to obtain a device as simple, yet critical, as a face mask.
Device manufactures have a good handle on how to relocate manufacturing into China; we’ve all been on at least one of those projects in our careers. But how do we move it back out? What are the obstacles and strategies for success?
In this show, we’ll discuss all of the hurdles you may encounter and talk with experts about strategies to overcome them.
Nancy Morrison, RAC — Executive Director of Regulatory and Quality Consulting Services, R&Q Dean Miller — Senior Principal Engineer, R&Q Jyothsna Nunna — Principal Engineer, R&Q Patrick Mahoney — Principal Specialist, R&Q
Lisa Casavant — Cofounder and Chief Strategy Officer, R&Q
R&Q's mission is to improve people's lives by providing industry-leading regulatory and quality consulting and engineering for medical devices, IVDs, and combination products. We help companies bring safe and effective products to market… and keep them there. Our team of 200+ consultants and counting have served over 300 companies around the globe. Subscribe to our blog, view our service offerings, watch free webinars, and more at RQTeam.com.
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