Return-Path: Delivered-To: charley@transocean.com Received: from vps.transocean.com by vps.transocean.com with LMTP id MDpIBx7B0FoZYAAAInt2oQ for ; Fri, 13 Apr 2018 07:39:26 -0700 Return-path: Envelope-to: charley@transocean.com Delivery-date: Fri, 13 Apr 2018 07:39:26 -0700 Received: from mta.email.complianceonline.com ([198.31.63.221]:16506) by vps.transocean.com with esmtp (Exim 4.89_1) (envelope-from ) id 1f6zrC-0006Sc-Lw for charley@transocean.com; Fri, 13 Apr 2018 07:39:26 -0700 DKIM-Signature: v=1; a=rsa-sha1; d=email.complianceonline.com; s=ei0; c=simple/simple; q=dns/txt; i=@email.complianceonline.com; t=1523629627; h=From:Subject:Date:To:MIME-Version:Content-Type; bh=v3tA5wlmvzaIK0k+ZeLXake3M5I=; b=BF1SBcPcqMQNJJjnf32mrGvrlxDCZ+ArztCaHaDhv8CQUU04FGIiQpM6wHQPCCBZ Ap3eFsGyn8g0oo4d32EeyY6+VCSoOUxKaqCKt+c1k+6ZsMyvLZviACc6wLKJNHvo Ul66moPsijzfpyDZvqvOVLbqa+mwfrTQJz/jgFaexrs=; Received: from [10.21.250.231] ([10.21.250.231:1264] helo=CORE18PUMPER1) by pc1udsmta1n15 (envelope-from ) (ecelerity 2.2.2.45 r(34222M)) with ESMTP id 96/59-15540-B3EB0DA5; Fri, 13 Apr 2018 10:27:07 -0400 Date: Fri, 13 Apr 2018 23:27:07 +0900 (JST) Message-Id: X-DMHA-ID-Packet: Z4gvK5o622gzTBxIWzQ7JzhVnbAQZ9UMYlyOFgUtkUt4De_dpgYtCVge0KEEXG9As2khkXNZfok= From: "compliance seminar" Reply-To: "Editor complianceonline" To: charley@transocean.com Subject: Learn Full Scope of IEC 60601-1, ISO 14708 & 14971 Risk Management IEC 60601-1 (3.1) The New Paradigm for Medical Device Safety | Seminar MIME-Version: 1.0 Content-Type: text/html; charset="us-ascii" Content-Transfer-Encoding: 7bit X-Spam-Status: No, score=0.1 X-Spam-Score: 1 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: ComplianceOnline ComplianceOnline The Largest GRC Advisory Network +1-888-717-2436 IEC 60601-1 (3.1) The New Paradigm for Medical Device Safety In-Person Seminar Minneapolis, MN | May 10-11, 2018 • View Agenda Speaker: Mike Colvin Ph.D, Medical Device Technical Adviser/Consultant This seminar provides an overview of the IEC 60601. It also covers the modified requirements presented in IEC 60601-1 Edition 3.1. Beginning with a brief summary of the history of the standard, the seminar then offers a detailed review of the significant additions and changes presented in Amendment 1, as well as information on other changes that may affect medical device manufacturers, and concludes with some guidelines and recommendations for manufacturers. Register Now Learning Objectives: [...] Content analysis details: (0.1 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: transocean.com] -0.0 SPF_PASS SPF: sender matches SPF record -0.5 BAYES_05 BODY: Bayes spam probability is 1 to 5% [score: 0.0150] 0.7 MIME_HTML_ONLY BODY: Message only has text/html MIME parts 0.0 HTML_MESSAGE BODY: HTML included in message 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 X-Spam-Flag: NO ComplianceOnline
ComplianceOnline
The Largest GRC Advisory Network 		+1-888-717-2436
IEC 60601-1 (3.1) The New Paradigm for Medical Device Safety
In-Person Seminar
Minneapolis, MN | May 10-11, 2018 • View Agenda
Speaker: Mike Colvin Ph.D, Medical Device Technical Adviser/Consultant

This seminar provides an overview of the IEC 60601. It also covers the modified requirements presented in IEC 60601-1 Edition 3.1. Beginning with a brief summary of the history of the standard, the seminar then offers a detailed review of the significant additions and changes presented in Amendment 1, as well as information on other changes that may affect medical device manufacturers, and concludes with some guidelines and recommendations for manufacturers.
Register Now

Learning Objectives:

After completing this seminar, participants should be familiar with the full scope of IEC 60601-1, including the current version. The topics covered will include:
  • Determine the applicable medical equipment requirements to design products for compliance
  • Risk Assessment, Designing a Risk Management system
  • Establishing essential performance limits on medical electrical equipment, and evaluating these performance characteristics under abnormal or fault conditions
  • Requirements for PEMS (programmable electrical medical systems)
  • Humidity testing requirements
  • Mechanical hazards
  • Temperature testing
  • Marking and labeling
  • Documentation, user manuals, instructions for use (IFU)
  • Define insulation parameters and requirements
  • Generate diagrams that determine creepage, clearance, insulation thickness, and dielectric strength requirements
  • Determine appropriate grounding, fire protection, and mechanical requirements
  • Identify performance testing
Speakers Profile:

Dr. Mike Colvin has over 30 years direct experience in managing Biocompatibility assessment and testing, working in the medical device and combination products field. He has worked on/contributed to many domestic and international Biocompatibility committees, and has been a consultant to the medical device industry on the proper Biocompatibility strategies for success.
View Details
4th Annual Medical Device Summit 2018 | San Francisco, CA | June 7-8, 2018
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