2-day In-person seminar on Medical Device Software Risk Management and Assurance Case at Boston, MA

Overview:

Gaps, incorrect or incomplete implementation of software can delay or make the certification/approval of medical 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. 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 concepts and content of safety assurance cases and will illustrate the usefulness for internal and external review of safety related information.

ABOUT SPEAKER –

Markus Weber

Principal Consultant, System Safety Inc. 

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.

Location: Location: Boston, MA        Date: 19th & 20th, June 2014        Time: 9 AM to 6 PM EDT 

Venue: Courtyard Boston Logan Airport 

Venue Address: 225 William F. McClellan Highway - Boston, Massachusetts 02128 USA

Price: $1,295.00 

Discount:

Register now and save $200. (Early Bird)

Until May 20, Early Bird Price: $1,295.00 
from May 21 to June 17, Regular Price: $1,495.00

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