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

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
Who will benefit:
Project Managers
Regulatory / Compliance Managers and Specialists
Quality Assurance Managers
System Engineering
Hardware Engineers
Software Engineers

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.

Contact Information:
Event Coordinator
Toll free: 800-425-9409
Fax: 302-288-6884
Email: support-AT-globalcompliancepanel.com
http://www.globalcompliancepanel.com
Price: $1,495.00
GlobalCompliancePanel
1000 N West Street, Suite 1200,
Wilmington, DE 19801, USA