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2 Day Course: Risk Management in Medical Devices Industry (Irving, TX, United States - February 15-16, 2018) - Research and Markets
[January 12, 2018]

2 Day Course: Risk Management in Medical Devices Industry (Irving, TX, United States - February 15-16, 2018) - Research and Markets


The "Risk Management in Medical Devices Industry" conference has been added to ResearchAndMarkets.com's offering.

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 oncepts and content of safety assurance cases and will illustrate the usefulness for internal and external review of safety related information.

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.

For more information about this conference visit https://www.researchandmarkets.com/research/jcl6zm/2_day_course?w=4


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