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Вміст надано RAQA Today and Michelle Lott. Весь вміст подкастів, включаючи епізоди, графіку та описи подкастів, завантажується та надається безпосередньо компанією RAQA Today and Michelle Lott або його партнером по платформі подкастів. Якщо ви вважаєте, що хтось використовує ваш захищений авторським правом твір без вашого дозволу, ви можете виконати процедуру, описану тут https://uk.player.fm/legal.
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eSTAR 5.0 - What You Must Know
Manage episode 413404905 series 2446473
Вміст надано RAQA Today and Michelle Lott. Весь вміст подкастів, включаючи епізоди, графіку та описи подкастів, завантажується та надається безпосередньо компанією RAQA Today and Michelle Lott або його партнером по платформі подкастів. Якщо ви вважаєте, що хтось використовує ваш захищений авторським правом твір без вашого дозволу, ви можете виконати процедуру, описану тут https://uk.player.fm/legal.
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.
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46 епізодів
Поширити
Manage episode 413404905 series 2446473
Вміст надано RAQA Today and Michelle Lott. Весь вміст подкастів, включаючи епізоди, графіку та описи подкастів, завантажується та надається безпосередньо компанією RAQA Today and Michelle Lott або його партнером по платформі подкастів. Якщо ви вважаєте, що хтось використовує ваш захищений авторським правом твір без вашого дозволу, ви можете виконати процедуру, описану тут https://uk.player.fm/legal.
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.
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46 епізодів
Усі епізоди
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Introducing The Unshakeables, a new podcast from Chase for Business and iHeartMedia's Ruby Studio. Small businesses are the heart and soul of this country, but it takes a brave individual to start and run a company of their own. From mom-and-pop coffee shops to auto-detailing garages -- no matter the type of industry you’re in, every small business owner knows that the journey is full of the unexpected. A single moment may even change the course of your business forever. Those who stand firm ...
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