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.

Date : 27th April 2017 to 28th April 2017

Place : United States, Seattle

Website :http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900888SEMINAR?channel=mailer&camp=Seminar&AdGroup=allconferencealerts_April_2017_SEO

Contact Person:John Robinson

Description:

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 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. will be held in Seattle,United States on date 2017-04-28

---

Deadline for abstracts/proposals : 25th April 2017

Keynote Speakers : 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 r

Conference Highlights :Day 1 Schedule Lecture 1: Introduction into Risk Management and Quality System Integration Why risk management? Historical perspective International regulatory / statutory requirements Risk Management Lifecycle and stakeholders Over-reaching concept Integration into ISO13485 Lifecycle steps Risk Management Benefits Liability issues Streamlining product development Improving product safety and quality How to Implement Risk Management into ISO13485 SOP framework Planning and ex

Venue :Courtyard Seattle Sea-Tac Area 16038 West Valley Highway Tukwila Washington 98188 USA Phone: (425) 255-0300

Check the event website for more details.