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Apr 7, 2016

Can’t-Miss Tips for Exposing Risk during Medical Device Development



The road to product success 
begins and ends with risk. 


 by Lisa Weeks, MasterControl  Communications


Do you confuse risk analysis with risk     assessment? Do you struggle to distinguish between a hazard and harm? Does the term risk management strike fear into your heart? If so, you’re not alone. Despite the publication of ISO 14971 in 2000 and, more recently, the inclusion of risk-based thinking among ISO 9001:2015 and ISO 13485:2016 requirements, many device manufacturers still struggle to understand, identify, assess and track risk across the product development lifecycle.



This article, originally posted by Qmed, explains the four phases of risk management (risk planning, risk assessment, risk control and risk review) and offers useful tips for exposing risk during product development. A 100% risk-free device is never attainable, but effective risk management can significantly reduce product failures, returns and sanctions. Read the full article.

This article is related to the Product Data Sheet: MasterControl Risk AnalysisTo get the full details, please download your free copy.



Lisa Weeks, a marketing communications specialist at MasterControl, writes extensively about technology, the life sciences and other regulated environments. She is a staff writer at GxP Lifeline and a contributor to many leading life science publications, including Medical Product Manufacturing News (MPMN) and CERM Risk Insights.







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Product Data Sheet: MasterControl Risk™
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