Can’t-Miss Tips for Exposing Risk during Medical Device Development
7 April, 2016 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.
|The road to product success
begins and ends with risk.
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-freedevice is never attainable, but effective risk management can significantly reduce product failures, returns and sanctions. Read the full article.
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.