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Medical Device Manufacturers Turn to Dyadem for Regulatory Compliance

Published 13 May 2010 | By Dyadem

As medical device manufacturers come under heavier scrutiny to ensure patient safety, they are increasingly turning to Dyadem for help implementing a quality risk management platform that can identify, analyze, mitigate and monitor quality risks throughout their organisations.

8 Feb 2010

Dyadem provides comprehensive quality risk management (QRM) solutions that enable global medical device companies to reduce risk management effort by 50 to 80 percent.

The US 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. Dyadem's software provides a framework for identifying, analyzing, mitigating and monitoring quality risks throughout the organisation. Without a quality risk management 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.

Diagnostic specialist DiaSorin has global operations that require the company to comply with a host of domestic and international quality regulations, including the IVD Directive, CE Marking, 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 harmonise 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," said Marco Pavan, QA project manager, DiaSorin.

Dyadem, the leader in operational and quality risk management, 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 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," said Andy Jobson, director of quality, 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."

Dyadem will host a live event on Monday 8 February 2010, for medical device manufacturers to discuss how they can proactively manage quality risk.

Consecutive presentations by industry experts:
Understanding Compliance Risk – Andy Jobson, director of quality, Moll Industries
The Evolution of Risk Management – Stewart Baillie, Director, product management, Dyadem

Date: 8 February 2010
Time: 3:00 p.m. – 6:00 p.m. followed by a catered networking reception
Location: Anaheim Hilton, Anaheim, CA

Dyadem will be exhibiting at MD&M West at booth #668 in the Quality Pavilion.