Upcoming Webinars
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Medical Device Compliance: A Practical Perspective
Join Dan Raymond, Founder of Springboard Solutions LLC who will provide a practical perspective of medical device compliance.
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Past Webinars
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Verification & Testing Strategies For Compliance With ISO 13485:2016, IEC 62304 / 60601-1 / 82304-1
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...
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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...
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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...
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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...
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