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April 20, 2022
In this special edition webinar series, Medmarc defense panel member, Jordan Lipp, Managing Member, Childs McCune, will lead an updated discussion about the PREP Act and COVID-19 two years later and...
April 12, 2022
This webinar will cover the following topics: What types of medical devices will require verification testing, and how to identify what standards your device needs to test to. Key aspects of these...
March 22, 2022
In our webinar held last July about the FDA’s Emergency Use Authorization (“EUA”), presenter Jianlin Song predicted that, as we get closer to the end of the pandemic, the FDA would release guidelines...
February 23, 2022
Change Management, especially related to a medical device’s design, is one of the most commonly-cited issues in FDA 483s and Warning Letters. Unfortunately, change is constant in the medical device...
January 26, 2022
The US Food and Drug Administration (FDA) continues to juggle enormous Covid-related responsibilities, while simultaneously attempting to make progress on a huge number of important regulatory...