{"id":5378,"date":"2024-01-25T10:00:12","date_gmt":"2024-01-25T09:00:12","guid":{"rendered":"https://briskr.nl/nl/?post_type=jku-events&#038;p=5378"},"modified":"2024-02-26T15:13:41","modified_gmt":"2024-02-26T14:13:41","slug":"fda-fundamentals","status":"publish","type":"jku-events","link":"https://briskr.nl/nl/events/fda-fundamentals/","title":{"rendered":"FDA Fundamentals"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">This FDA Fundamentals course will lay out key expectations and processes required to achieve FDA clearance of your device to the US Market. It will provide direction on how and where to start with product development and ultimately, steps to preparing FDA submissions.&nbsp;Don&#8217;t miss out! Join us on March 7!</p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Topics we will discuss are:</strong></p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Brief history of FDA – what led to creation of FDA</li>\n\n\n\n<li>FDA structure</li>\n\n\n\n<li>Device classification and general requirements</li>\n\n\n\n<li>FDA guidance documents and tips to navigate the FDA website</li>\n\n\n\n<li>Submission types – what, when, how</li>\n\n\n\n<li>Development steps leading up to a successful submission</li>\n</ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Speaker:</strong></p>\n\n\n\n<p class=\"wp-block-paragraph\">Lorry Weaver, MLS(ASCP), CLS, Principal Consultant, Regulatory Affairs</p>\n\n\n\n<p class=\"wp-block-paragraph\">Qserve Group, US</p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"191\" height=\"97\" src=\"https://briskr.nl/wp-content/uploads/2024/01/NEW-logo-Qserve-lage-resolutie.jpg\" alt=\"\" class=\"wp-image-5380\"/></figure>\n\n\n\n<p class=\"wp-block-paragraph\"><br><strong>Location</strong><br>Noviotech Campus Nijmegen, building M, Meet&amp;Greet area. Transistorweg 5</p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Good to know</strong><br>The workshop is facilitated in <strong>English</strong>. Participation in the workshop is free for everyone, including drinks and bites. However, for cancellations within 24 hours prior to the event, we will charge a fee of 15 euros (excluding VAT) to cover expenses.</p>\n\n\n\n<div id=\"subscribe-event-block_12d08920f826c8ddd55130ad0cf832fa\" class=\"block subscribe-event acf-subscribe-event wp-block-group alignfull has-primary-background-color has-background\">\n  <div class=\"wp-block-group__inner-container\">\n    <div class=\"row\">\n      <div class=\"col-md-5 order-2 order-md-1\">\n        <div class=\"wp-block-buttons\">\n          <div class=\"wp-block-button\">\n            <a class=\"wp-block-button__link no-border-radius\" href=\"#\">Subscribe for this workshop</a>\n          </div>\n        </div>\n      </div>\n      <div class=\"col-md-7 order-1 order-md-2\">\n              </div>\n    </div>\n    <div class=\"row formwrapper\">\n      <div class=\"col\">\n                <p class=\"wpcf7-contact-form-not-found\"><strong>Error:</strong> Contact form not found.</p>      </div>\n    </div>\n  </div>\n</div>\n","protected":false},"excerpt":{"rendered":"<p>This FDA Fundamentals course will lay out key expectations and processes required to achieve FDA clearance of your device to the US Market. It will&#46;&#46;&#46;</p>\n","protected":false},"featured_media":5379,"template":"","categories":[2],"tags":[8],"jku-businessfase":[11,10,9],"class_list":["post-5378","jku-events","type-jku-events","status-publish","has-post-thumbnail","hentry","category-regulations","tag-health","jku-businessfase-start-up","jku-businessfase-scale-up","jku-businessfase-grown-up"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.8 - https://yoast.com/product/yoast-seo-wordpress/ -->\n<title>FDA Fundamentals - Briskr</title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" />\n<link rel=\"canonical\" href=\"https://briskr.nl/nl/events/fda-fundamentals/\" />\n<meta property=\"og:locale\" content=\"nl_NL\" />\n<meta property=\"og:type\" content=\"article\" />\n<meta property=\"og:title\" content=\"FDA Fundamentals - Briskr\" />\n<meta property=\"og:description\" content=\"This FDA Fundamentals course will lay out key expectations and processes required to achieve FDA clearance of your device to the US Market. 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