VIEWS: 68 PAGES: 2 CATEGORY: Healthcare & Medicine POSTED ON: 8/1/2012
This seminar covers the compliance issues relating to ISO14971, IEC62304 and IEC60601-1:2005. Especially the cross-standard and practical means to integrate activities to cover all three requirements documents is presented.
View this email in your browser | Unsubscribe from future mailings 2-day In-person Seminar on Risk Management: ISO14971, IEC62304 and IEC60601-1: 2005 Compliance Course "Risk Management: ISO14971, IEC62304 and IEC60601-1: 2005 Compliance" has been pre-approved by Register Now RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Date & Time: Instructor Profile: October 04th and 05th 2012 8 AM to 5 PM EDT Markus Weber Duration: 2 Days Instructor: Markus Weber Principal Consultant, System Safety Inc. Price : $1295.00 (for one Location: San Diego participant) Markus Weber, Principal Register for 4 Participants to Get 1 Free Pass Consultant with System Safety, Inc., specializes in safety engineering and risk management for critical medical devices. He graduated from Ruhr Overview: University in Bochum, Germany with This seminar covers the compliance issues relating to ISO14971, a MS in Electrical Engineering. IEC62304 and IEC60601-1:2005. Especially the cross-standard and Before founding System Safety, Inc., practical means to integrate activities to cover all three requirements he was a software safety engineer documents is presented. for the German approval agency, TUV. Since 1991, Mr. Weber has been a leading consultant to the Course Outline: medical device industry on safety and regulatory compliance issues, specifically for active and software- Course Outline: Day 1: controlled devices. In conjunction with the FDA, he has published Lecture 1: (ISO 14971): works on risk management issues and software-related risk l Risk Management Planning mitigations. Mr. Weber has helped l Risk Management Life Cycle multiple companies, from startups to Fortune 500 firms. ...more l Hazard Identification l Hazard Domains l Hazard Latency Issues l Risk Rating Methods Suggest a Topic More Webinars l Initial (unmitigated) Risk Assessment Your Necessity is our Priority l Mitigation Strategies and Priorities l Mitigation Architectures Lecture 2: (ISO 14971): l Alarm Systems as Mitigations l Risk Control Bundles l Post Mitigation Risk l Residual Risk l Safety Integrity Levels l Usability as Hazard Source and Mitigation l Safety Requirements l Hazard Mitigation Traceability l Verification Planning l Architectures, Redundancy and Diversity l Failure Mode and Effect Analysis / FTA l Verification Strategies l System Validation / Mitigation Validation Course Outline: Day 2: Lecture 3: (IEC60601-1:2005): l References to Risk Management l Section 4 Risk Related Issues l Compliance for Non-Software Related Issues l The IEC TRF (technical report form) l Special PEMS Issues l PEMS and IEC62304 Lecture 4: (IEC62304): l Critical Software Issues l Software Hazard Mitigation Strategies l Software Item, Unit and System Definition l Software Failures as Hazard Sources l Software Requirements and Design Specification l Software Tools and Development Environment l Software Unit and Integration Testing l Real-Time System Challenges l Software Verification and Validation l Mitigation Traceability and Effectiveness Click here to register for this seminar Who Will Benefit: l Project Managers l Regulatory / Compliance Managers and Specialists l Quality Assurance Managers l System Engineering l Hardware Engineers l Software Engineers It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals. GlobalCompliancePanel www.globalcompliancepanel.com 1000 N West Street Suite, 1200 Wilmington DE 19801 Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe
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