eSTAR 5.0 - What You Must Know
Update: 2024-04-19
Description
This is not last year's eSTAR - a LOT has changed, and there are things you need to know before you try to submit your 510k.
In this episode, we'll guide you through the intricacies of the latest eSTAR 5.0 platform, crucial for those of you planning a 510k or PMA submission.
We'll review the eSTAR 5.0 platform and what you need to know to use it effectively –the good, the bad, and the ugly.
The new features, including premarket approval content and updated cybersecurity documentation and dive into the simplified EMC questions, revised sterility section, and new biocompatibility testing options - we'll cover it all.
LinkedIn: https://www.linkedin.com/in/michellelottraqa
Website: https://leanraqa.com/
YouTube: https://www.youtube.com/@leanRAQA
Instagram: https://www.instagram.com/leanraqa
In this episode, we'll guide you through the intricacies of the latest eSTAR 5.0 platform, crucial for those of you planning a 510k or PMA submission.
We'll review the eSTAR 5.0 platform and what you need to know to use it effectively –the good, the bad, and the ugly.
The new features, including premarket approval content and updated cybersecurity documentation and dive into the simplified EMC questions, revised sterility section, and new biocompatibility testing options - we'll cover it all.
LinkedIn: https://www.linkedin.com/in/michellelottraqa
Website: https://leanraqa.com/
YouTube: https://www.youtube.com/@leanRAQA
Instagram: https://www.instagram.com/leanraqa
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