Return-Path: Delivered-To: louk@transocean.com Received: from vps.transocean.com by vps.transocean.com with LMTP id mDALNoSv2FqZYQAAInt2oQ for ; Thu, 19 Apr 2018 08:02:28 -0700 Return-path: Envelope-to: louk@transocean.com Delivery-date: Thu, 19 Apr 2018 08:02:28 -0700 Received: from omp.news.grceducators.com ([129.145.68.217]:53776 helo=om-axonstech.rsys2.com) by vps.transocean.com with esmtp (Exim 4.89_1) (envelope-from ) id 1f9B4m-0006UU-WD for louk@transocean.com; Thu, 19 Apr 2018 08:02:28 -0700 DKIM-Signature: v=1; a=rsa-sha256; c=relaxed/relaxed; s=grceducators; d=news.grceducators.com; h=MIME-Version:Content-Type:Content-Transfer-Encoding:Date:To:From:Reply-To: Subject:List-Unsubscribe:Message-ID; i=grceducators@news.grceducators.com; bh=o/jMQ4PHrMpEfyAKtkN5NOHog0JCiJkmwRrdql99Qt4=; b=O7FjHsYTOemOZllHHzSA8fxTVeUOI9/AuSlJ+NrXVGo1gStmrH/nSDIJewHHz1PnKoFMpKoAG6y4 OWLyVlaNF9L3kqKm+wU0HW/5sPXD77EaPm9WH+Ax23Wq/eITq5bb3ivFUQZ2iUzVeHTSug/ojsOG Q9rSA975EWoxjdtXedSaoiTIBzrPVQR3rjOUZS369TPC8TDwwCfsPOz+unw8HlxRLw2NT5GVLJTS O3mcQ5AV01vlCHZ0Sb6NUWKpzYfGyPn3TzFf22MFTYMOWb+Q5npG1wwADybxUd6XdNZIMc8P+NaV s0mV8sApJZ4tDGhxlOfE9ryXoeen1emPD44UQQ== Received: by om-axonstech.rsys2.com id hr2nnq2b610s for ; Thu, 19 Apr 2018 08:01:31 -0700 (envelope-from ) X-CSA-Complaints: whitelist-complaints@eco.de MIME-Version: 1.0 Content-Type: text/html; charset="ISO-8859-1" Content-Transfer-Encoding: quoted-printable Date: Thu, 19 Apr 2018 08:01:31 -0700 To: louk@transocean.com From: =?ISO-8859-1?B?V2ViaW5hciBVcGRhdGVz?= Reply-To: =?ISO-8859-1?B?V2ViaW5hciBVcGRhdGVz?= Subject: Preparing a FDA 510(k) Submission Feedback-ID: 10775:178222:oraclersys List-Unsubscribe: , X-sgxh1: thmsxljHgkhJLHgQJhu X-rext: 5.interact2.EozpUh876fjXV6QwUSvgZyUYvngQYMYh0gIdpgOqYhgbnIA X-cid: axonstech.179122 Message-ID: <0.1.435.EE0.1D3D7EF4D6A243C.0@om-axonstech.rsys2.com> X-Spam-Status: No, score=2.4 X-Spam-Score: 24 X-Spam-Bar: ++ X-Ham-Report: Spam detection software, running on the system "vps.transocean.com", has NOT identified this incoming email as spam. The original message has been attached to this so you can view it or label similar future email. If you have any questions, see root\@localhost for details. Content preview: Preparing a FDA 510(k) Submission Tuesday, May 15 2018 | 1:00 PM EST | 60 Minutes Course Summary [...] Content analysis details: (2.4 points, 3.0 required) pts rule name description ---- ---------------------- -------------------------------------------------- 0.0 URIBL_BLOCKED ADMINISTRATOR NOTICE: The query to URIBL was blocked. See http://wiki.apache.org/spamassassin/DnsBlocklists#dnsbl-block for more information. [URIs: mailinblue.com] -0.0 SPF_PASS SPF: sender matches SPF record 0.0 HTML_MESSAGE BODY: HTML included in message 0.0 T_KAM_HTML_FONT_INVALID BODY: Test for Invalidly Named or Formatted Colors in HTML 0.7 MIME_HTML_ONLY BODY: Message only has text/html MIME parts 0.0 HTML_FONT_LOW_CONTRAST BODY: HTML font color similar or identical to background 0.8 BAYES_50 BODY: Bayes spam probability is 40 to 60% [score: 0.5000] 0.1 DKIM_SIGNED Message has a DKIM or DK signature, not necessarily valid -0.1 DKIM_VALID_AU Message has a valid DKIM or DK signature from author's domain -0.1 DKIM_VALID Message has at least one valid DKIM or DK signature 1.0 FROM_EXCESS_BASE64 From: base64 encoded unnecessarily X-Spam-Flag: NO <=21DOCTYPE html PUBLIC =22-//W3C//DTD XHTML 1=2E0 Transitional//EN=22 =22h= ttp://www=2Ew3=2Eorg/TR/xhtml1/DTD/xhtml1-transitional=2Edtd=22> Preparing a FDA 510(k) Submission <=21--=5Bif gte mso 11=5D><=21=5Bendif= =5D--><=21--=5Bif =21mso=5D><=21--> <=21--<=21=5Bendif=5D--><=21--=5Bif gte mso 15=5D>96<=21=5Bendif=5D--><=21--=5Bif gte mso 9=5D>96<=21=5Bendif=5D-->
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Tuesday, May 15 2018 =7C 1:00 PM EST =7C 60 Minutes
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Course Summary
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Preparing a submission to get FDA approval f= or a new product is time consuming and confusing=2E The submission requirem= ents refer to many unfamiliar concepts and terms=2E More than half of all s= ubmissions are rejected=2E We will teach you to prepare a submission meetin= g all the FDA requirements=2E

We will explain what a 510(k= ) is and the procedure to prepare the submission=2E the several types of 51= 0(k) will be explained=2E Each part of the submission will be explained=2E = The very confusing concepts of predicate device and substantial equivalence= will be discussed=2E How to find an acceptable predicate device will be ta= ught=2E FDA places special emphasis on device software=2E we will cover the= requirements for software=2E
 
<= strong>Learning Objective
  • 510(k) unique terminolo= gy
  • Refuse To Accept policy
  • what is a predicate device
  • Selecting a predicate device (substantial equivalence= )
  • Here to find substantially equivalent predicate devic= es
  • How to handle software
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Register Now
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Upcoming Webinars
Upcoming Webinars
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Event Marketing =7C GRC Educators =7C 740-870-0321 =7C support=40grcedu= cators=2Ecom =7C www=2Egrceducators=2Ecom =7C 806 Clark Street, P=2EO Box 1= 71, Philo, OH-43771 USA
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