Risk Management in Medical Devices Industry – US Seminar 2012

Mar 25, 18 Risk Management in Medical Devices Industry – US Seminar 2012

Risk Management in Medical Devices Industry – US Seminar 2012 at Boston

Overview: The course can introduce the main components of risk administration and the use of risk management concepts and requirements to the medical gadget development cycle. Risk administration has become the technique of choice to make sure an effective and basic safety oriented device advancement. International consensus, reflected in globally relevant standard requirements, has resulted in risk administration as a mandatory element of nearly every activity in the medical gadget industry.

The course will emphasise the implementation of risk administration into the advancement and maintenance process. It’ll use real-life illustrations and proven guidelines to help make the application of risk administration a practical and helpful undertaking.

This seminar will address the machine level issues of risk management and also the increasingly important software related issues of critical systems. It can help to adhere to regulatory requirements with minimized overhead and reference burden.

Thinking about attend: Gaps, incorrect or incomplete implementation may delay or produce the certification/acceptance of products impossible. Many activities can’t be retroactively performed being that they are carefully linked into the advancement lifecycle. Diligent, comprehensive and correct execution of risk management right away of product advancement is therefore imperative.

Course Modules & Content Information:

Day 1, April 12, 2012

Lecture 1:Risk administration planningRisk management lifestyle cycleHazard identificationHazard domainsHazard latency issuesRisk ranking methodsInitial (unmitigated) risk assessmentQ&A SessionLecture 2:Mitigation strategies and prioritiesMitigation architecturesAlarm systems seeing that mitigationsRisk control bundlesPost mitigation riskResidual riskSafety Integrity levelsQ&A SessionDay 2, April 13, 2012

Lecture 3:Usability seeing that hazard supply and mitigationSafety requirementsHazard mitigation traceabilityVerification planningArchitectures, redundancy and diversityFailure setting and effect evaluation / FTAVerification strategiesSystem validation / mitigation validationQ&A SessionLecture 4:Critical software program issuesSoftware hazard mitigation strategiesSoftware item, unit and program definitionSoftware failures seeing that hazard sourcesSoftware requirements and style specificationSoftware tools and advancement environmentSoftware device and integration testingReal-time program challengesSoftware verification and validationMitigation traceability and effectivenessQ&A Session

Who will benefit:Task ManagersRegulatory / Compliance Managers and SpecialistsQuality Assurance ManagersSystem EngineeringHardware EngineersSoftware Engineers

Markus Weber, Principal Consultant with Program Safety, Inc., specializes safely engineering and risk administration for critical medical gadgets. He graduated from Ruhr University in Bochum, Germany with a MS in Electrical Engineering. Before founding Program Basic safety, Inc., he was a software program basic safety engineer for the German acceptance agency, TUV. Since 1991, Mr. Weber is a leading consultant to the medical gadget industry on basic safety and regulatory compliance problems, specifically for energetic and software-controlled devices. With the FDA, he provides published functions on risk management problems and software-related risk mitigations. Mr. Weber provides helped multiple businesses, from startups to Fortune 500 firms.

Date & Venue:

April 12th and April 13th 2012 at Boston Marriott Long Wharf8 AM PDT to 5 PM PDT

Price: $1,695.00

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