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...
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...
December 15, 2021
In this year’s annual year-end wrap-up, a panel that includes members of Medmarc’s Claims Department, Megan Grossman of Lewis Brisbois Bisgaard & Smith, and Karen Shimonsky of Gordon Rees Scully...
November 18, 2021
The answer is both no and yes. It is widely believed that good design transcends the need for specialized knowledge – the product itself should demonstrate what it is capable of by utilizing its...
October 27, 2021
Attendees to this webinar will learn more about the following: What is Human Factors/Usability Engineering (HF/UE) for medical products? What are the regulatory bodies asking for around HF/UE? How...
August 19, 2021
This webinar will discuss legislative action across the nation surrounding the topic of the “right to repair.” What started as a competition-driven movement for electronic devices such as phones and...
July 27, 2021
EUA is an expedited and temporary pathway for the FDA to approve a medical product in times of emergency. Since the COVD-19 pandemic, the FDA has issued nearly 400 EUAs approving a wide spectrum of...