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Seminar on

Risk Management in Medical Devices Industry

Date & Time: April 12th and April 13th 2012

9 AM PDT to 5 PM PDT

Duration: 2 Days

Instructor: Markus Weber

Location: Boston

Price : $1695.00


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(for one


Instructor Profile: Markus Weber Principal Consultant, System Safety Inc.

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

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 softwarecontrolled 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. ...more

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 a s 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.

Areas Covered in the Session: Day 1, April 12, 2012 Lecture 1: l l l l l l l l

Suggest a Topic

Risk management planning Risk management life cycle

Your Necessity is our Priority

Hazard identification Hazard domains Hazard latency issues Risk rating methods

Initial (unmitigated) risk assessment Q&A Session

Lecture 2: l l l l l l l l

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: l l l l

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

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More Webinars

Lecture 4: l l l l l l l l l l l

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

Click here to register for this webinar Who Will Benefit: l l l l l l

Project Managers Regulatory / Compliance Managers and Specialists Quality Assurance Managers System Engineering Hardware Engineers 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 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

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

The course will introduce the main elements of risk management and the application of risk management principles and requirements to the med...