MEDICAL DEVICES INDUSTRY 2017 - Medical Devices Industry and Risk Management 2017
View: 124
Website http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900888SEMINAR?channel=mailer |
Edit Freely
Category Medical Devices Industry and Risk Management 2017
Deadline: April 27, 2017 | Date: April 27, 2017-April 28, 2017
Venue/Country: Seattle, WA, U.S.A
Updated: 2017-03-01 20:04:16 (GMT+9)
Call For Papers - CFP
Overview:Gaps, incorrect or incomplete implementation of software can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical device software in a regulatory compliant environment. Software risk management has to be embedded into the bigger scope of overall risk management. Therefore this course will additionally address the system level risk management and the resulting interfaces to software.To comprehensively summarize all risk related activities and to demonstrate the safe properties of a device the 'Safety Case' or 'Assurance Case' document is a well-established method to collect all safety related information together in one place. This documentation will most likely become mandatory for all devices (currently only required for FDA infusion pump submissions). This course will introduce the basic concepts and content of safety assurance cases and will illustrate the usefulness for internal and external review of safety related information.Who will benefit:The course will introduce the main elements of risk management with emphasis on software issues and the application of risk management principles and requirements to the medical device development cycle. Risk management has become the method of choice to ensure an effective and safety oriented device development. International consensus, reflected in globally applicable standard requirements, has led to risk management being a mandatory component of almost any activity in the medical device industry.The course will emphasize the implementation of risk management into the development and maintenance process. It will use real-life examples and proven tips and tricks to make the application of risk management a practical and beneficial undertaking. This seminar will address the system level issues of risk management as well as the increasingly important software related issues of critical systems. It will help to comply with regulatory requirements with minimized overhead and resource burden. To make the combines effort to design, implement and verify a safe device transparent the concept of an assurance case will be introduced.The course is mainly based on international consensus requirements such as ISO14971 and IEC62304.Following personnel will benefit from the course:• Senior Quality Managers• Quality Professionals• Regulatory Professionals• Compliance Professionals• Project Managers• Design Engineers• Software Engineers• Process Owners• Quality Engineers• Quality Auditors• Medical Affairs• Legal ProfessionalsAgenda:Lecture 1:Introduction into Risk Management and Quality System Integration• Why risk management?o Historical perspectiveo International regulatory / statutory requirements• Risk Management Lifecycle and stakeholderso Over-reaching concepto Integration into ISO13485o Lifecycle steps• Risk Management Benefitso Liability issueso Streamlining product developmento Improving product safety and quality• How to Implement Risk Management into ISO13485o SOP frameworko Planning and executiono Monitoring and control• Tips and tricksLecture 2:Risk Management to ISO 14971:2012• Risk Management Planning• Risk Management Life Cycle• Hazard Identificationo Hazard Domainso Hazard Latency Issueso Risk Rating Methods• Initial (unmitigated) Risk Assessment• Mitigation Strategies and Priorities• Mitigation Architectureso Alarm Systems as Mitigationso Risk Control Bundles• Post Mitigation Risk• Residual Risko Safety Integrity Levels• European special requirements (Z-Annexes)• Safety Requirements• Hazard Mitigation Traceability• Verification Planning• Architectures, Redundancy and Diversity• Failure Mode and Effect Analysis• Tips and Tricks• Q&ADay 2 ScheduleLecture 1:Software Risk Management (IEC62304 / FDA software reviewers' guidance):• Critical Software Issues• Software Hazard Mitigation Strategies• Software Item, Unit and System Definition• Software Failures as Hazard Sources• Software Requirements and Design Specification• Software Tools and Development Environment• Software Unit and Integration Testing• Real-Time System Challenges• Software Verification and Validation• Mitigation Traceability and Effectiveness• Software Maintenance and Configuration Control• Software Risk Management Process integration into ISO14971• Legacy Software issues• FDA documentation requirements• Upcoming changes in IEC62304:2014• Tips and Tricks• Q&ALecture 2:Safety / Assurance case• Safety classeso Basic Safety / Environmento Essential performance• Documentation of Basic Safetyo Electrical Safetyo Mechanical Safetyo EMC / RFI safetyo Safety margins• Documentation of essential performanceo What is essential performance?o Device architectures and mitigation allocationo Device specific mitigationso Software mitigations• External safetyo User intervention and alarmso Organizational measureso Levels of protection concept• Verification of safety propertieso Type testingo Sample testingo Software verification testingo Inspectionso Analyses• Assurance case vs. Risk Management Reporto General safety and hazard avoidanceo Device / application specific issues• Tips and Tricks• Q&ASpeaker:Markus Weber,Principal Consultant, System Safety Inc. Markus Weber, Principal Consultant with System Safety, Inc., specializes in safety engineering and risk management for critical medical devices. He graduated from Ruhr University in Bochum, Germany with a MS in Electrical Engineering. Before founding 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 regulatory compliance issues, specifically for active and software-controlled devices. In conjunction with the FDA, he has published works on risk management issues and software-related risk mitigations. Mr. Weber has helped multiple companies, from startups to Fortune 500 firms.Location: Seattle, WADate: April 27th & 28th, 2017 and Time: 9:00 AM to 6:00 PMVenue: Courtyard Seattle Sea-Tac AreaAddress: 16038 West Valley Highway Tukwila Washington 98188 USA Phone: (425) 255-0300Price:Register now and save $200. (Early Bird)Price: $1,295.00 (Seminar Fee for One Delegate)Until March 20, Early Bird Price: $1,295.00 From March 21 to April 25, Regular Price: $1,495.00Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*Quick Contact:NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407Fax: 302-288-6884Email: supportglobalcompliancepanel.com Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel?Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/Follow us on Twitter: https://twitter.com/GCPanel
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.