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FDA Compliance

Medical Device Manufacturers Turn to Dyadem for Regulatory Compliance

QRM platform that can identify, analyze, mitigate, and monitor quality risks

Published: Tuesday, February 23, 2010 - 14:24

(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. 

The diagnostic specialist group, DiaSorin, has global operations that require the company to comply with a host of domestic and international quality regulations, including the IVD Directive, CE Mark, ISO 14971, and various FDA mandates. DiaSorin’s facilities operate independently from each other, but needed a common way to assess risk and unify quality.

“We wanted to harmonize the approach to risk analysis for both product and process. Dyadem meets all of our needs and allows DiaSorin to continue to set high standards for quality and ensure customer safety,” says Marco Pavan, quality assurance project manager at DiaSorin.

Dyadem, a provider of operational and QRM, provides software and consulting to many medical device leaders such as Boston Scientific, Covidien, Roche Diagnostics, Moll Industries, Ventana Medical Systems, DiaSorin and Bespak.

Dyadem’s software has allowed the Dallas, Texas-based medical device contract manufacturer, Moll Industries, to standardize the quality planning process across its plants in the United States and Ireland. “To get a competitive edge you must have quality in your manufacturing processes,” says Andy Jobson, director of quality at Moll Industries. “Making a product right the first time and every time thereafter is the cheapest way to manufacture. Dyadem’s software provides us with the proper visibility into our processes to ensure high quality.”


About The Author

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Dyadem is a provider of operational risk management and quality risk management solutions. Dyadem provides software and services that empower companies to discover and manage the risks to people and products in the design and manufacturing processes. Dyadem helps some of the world’s largest companies achieve regulatory compliance and business continuity, serving the oil and gas, chemical, mining, pharmaceutical, medical, automotive, electronics, and aerospace and defense industries. For more information, visit www.dyadem.com.