Event Detail
Risk Management in Medical Devices Industry - US Seminar 2012 at Boston
April 12 - 13, 2012 - Boston Marriott Long Wharf ,8 AM to 5 PM EDT DE US
GlobalCompliancePanel
support@globalcompliancepanel.com
Phone: 8004479407
Overview: The course will introduce the main elements of risk management 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 as a mandatory component of almost any activity in the medical device industry. The course will emphasise 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. Why should you attend: Gaps, incorrect or incomplete implementation can delay or make the certification/approval of 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. Course Modules & Content Details: Day 1, April 12, 2012 Lecture 1: Risk management planning Risk management life cycle Hazard identification Hazard domains Hazard latency issues Risk rating methods Initial (unmitigated) risk assessment Q&A Session Lecture 2: Mitigation strategies and priorities Mitigation architectures Alarm systems as mitigations Risk control bundles Post mitigation risk Residual risk Safety Integrity levels Q&A Session Day 2, April 13, 2012 Lecture 3: Usability as hazard source and mitigation Safety requirements Hazard mitigation traceability Verification planning Architectures, redundancy and diversity Failure mode and effect analysis / FTA Verification strategies System validation / mitigation validation Q&A Session Lecture 4: 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 Q&A Session Contact Information: Event Coordinator Toll free: 800-425-9409 Fax: 302-288-6884 Email: support@globalcompliancepanel.com http://www.globalcompliancepanel.com Price: $1,495.00 GlobalCompliancePanel 1000 N West Street, Suite 1200, Wilmington, DE 19801, USA