(Dyadem: Toronto, Ontario) -- As medical device manufacturers come under heavier scrutiny to ensure patient safety, they are increasingly looking to quality risk management (QRM) software that can identify, analyze, mitigate, and monitor quality risks throughout their organizations. Dyadem provides comprehensive QRM solutions that enable global medical device companies to reduce risk management effort by 50 to 80 percent.

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency closely regulate the medical device industry, ensuring that patient safety is never compromised by inadequate quality management or the competitive rush to market. Yet, inherently, medical devices pose certain risks in their application, whether during production, implementation, or post-implementation. 

The FDA and the European Medicines Agency require documentation of risk assessment procedures and quality monitoring of all medical devices. Without a QRM system, device manufacturers drastically increase their exposure to a host of business risks, including time-to-market delays, inflated manufacturing costs, and significant penalties from regulatory bodies. 

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