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Medical Device Software Risk Management Standard | Software Expert 2018

DoubleTree by Hilton San Diego Downtown

Thursday, January 18, 2018

 

 

Engineers are dedicated to making things work, so a focus on how they might fail and harm someone can seem alien. Managing risk, however, is essential for all medical products- medical devices, including those involving software, have produced some painful examples of poor risk management with serious consequences. Experience has shown that there is a better way, that it is possible to manage risk in a changing business and technical world. Regulatory bodies are placing increased emphasis on risk management, and technology shifts are introducing new sources of risk. Newer Lean-Agile methods are recognized by the FDA as a good way to accomplish risk management. Techniques for risk management are well established, but require specific interpretation when applied to software. In this session, we will show a way of knitting risk management into the development process, so that it is integral to product development, not a ten ton caboose dragging the train back down the mountain. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901345SEMINAR?wooeb-January-2018-SEO

 

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