Upcoming Webinars
-
FDA QSR to QMSR: Regulatory, Legal, and Risk Implications for Industry
In this webinar, Denise Holliday, Expert Witness at Capwell Consulting Group, helps you understand how the transition to QMSR may affect regulatory compliance, product liability exposure, and organizational risk.
Register for FDA QSR to QMSR: Regulatory, Legal, and Risk Implications for Industry Read More about FDA QSR to QMSR: Regulatory, Legal, and Risk Implications for Industry
Past Webinars
-
Out of EUA— FDA’s Guidance & Recommendations
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...
Read More about Out of EUA— FDA’s Guidance & Recommendations -
How to Effectively Evaluate Change and Incorporate Findings into Biocompatibility Testing and Justifications
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...
Read More about How to Effectively Evaluate Change and Incorporate Findings into Biocompatibility Testing and Justifications -
FDA Outlook for 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...
Read More about FDA Outlook for 2022 -
Claims 2021: Another Year Unlike Any Other
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...
Read More about Claims 2021: Another Year Unlike Any Other