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DTSTAMP:20260521T114742Z
SUMMARY:Seminar on Medical Device Software Development at SFO, CA
DESCRIPTION:Overview:\nThis seminar is mainly based on the IEC62304:20
 06 standard and will introduce the main elements and requirements for 
 the development of modern software systems for medical devices. Emphas
 is is placed on understanding the underlying principles that generate 
 the requirements of the standard, to understand strengths, the shortco
 mings and weak parts of the standard and give practical, proven guidan
 ce on how to implement the requirements necessary for regulatory appro
 val. This seminar goes beyond teaching the mere content of the standar
 d, but will provide the toolset to understand the underlying engineeri
 ng principles that allow a justifiable interpretation of potential amb
 iguities of regulatory requirements. Understanding the basic principle
 s of risk management, the failure modes of software, the architectural
  approaches available to mitigate software failures and the understand
 ing of test methodologies are vital components to understand the 'spir
 it' of the requirements.\nSoftware risk management has to be embedded 
 into the bigger scope of overall risk management. Therefore, this cour
 se will additionally link to the system level risk management and the 
 resulting interfaces to software. Risk probability and the impact on s
 oftware based risk reduction will be discussed.\nWho will benefit:\nTh
 is course is developed to provide valuable assistance to all regulated
  companies that need to understand their software development processe
 s including companies:\n\nSenior Quality Managers\nQuality Professiona
 ls\nRegulatory Professionals\nCompliance professionals\nProject Manage
 rs\nSoftware Project Managers\nDesign Engineers\nSoftware Engineers\nP
 rocess Owners\nQuality Engineers\nQuality Auditors\n\nSpeaker:\nMarkus
  Weber is the owner and Principal Consultant with System Safety, Inc.
  He specializes in safety engineering and risk management for critical
  medical devices. With his background in embedded systems engineering 
 (MSEE) Mr. Weber provides safety and regulatory compliance consulting 
 to multiple industries for more than 20 years. Before founding his con
 sulting company, System Safety, Inc. he was a software safety engineer
  for the German approval agency, TUV. Since 1991, Mr. Weber has been a
  leading consultant to the medical device industry on safety and regul
 atory compliance issues, specifically for active and software-controll
 ed devices. He teaches webinars, seminars and university courses on a 
 regular basis.\nLocation: SFO, CA        Date: August 6th & 7t
 h, 2015        Time: 9 AM to 6 PM  Venue: DoubleTree by Hilto
 n Hotel San Francisco Airport\nVenue Address: 835 Airport Blvd., Burli
 ngame CA 94010-9949\nPrice: $1,645.00 (Seminar for One Delegate)\nRegi
 ster now and save $200. (Early Bird)\nUntil June 30, Early Bird Price:
  $1,645.00\nFrom July 01 to August 04, Regular Price: $1,845.00\nConta
 ct Information:\nNetZealous LLC,\nDBA GlobalCompliancePanel\n161 Missi
 on Falls Lane,\nSuite 216, Fremont, CA 94539, USA         \nU
 SA Phone: 800-447-9407\nFax: 302-288-6884\nsupport@globalcompliancepan
 el.com          \nhttp://www.globalcompliancepanel.com\nEven
 t Registration Link - http://bit.ly/1EfIMDP\n\nFor more information vi
 sit https://medtechiq.ning.com/events/seminar-on-medical-device-softwa
 re-development-at-sfo-ca
DTSTART;TZID=America/New_York:20150806T090000
DTEND;TZID=America/New_York:20150807T180000
CATEGORIES:clinical, food, fda, medical, device, defence, and, navy, a
 erospace, mining
LOCATION:DoubleTree by Hilton Hotel San Francisco Airport
WEBSITE:https://www.globalcompliancepanel.com
URL:https://www.globalcompliancepanel.com
CONTACT:18004479407
ORGANIZER:GlobalCompliancePanel
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562011438?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="John Rob
 inson":https://medtechiq.ning.com/profile/JohnRobinson
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