2010-02-08 22:28:47 -
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 organizations. 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 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.
Dyadem’s software provides a framework for identifying, analyzing, mitigating and monitoring quality risks throughout the organization.
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 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,” 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, February 8, 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: February 8, 2010
Time: 3:00 p.m. – 6:00 p.m. followed by a catered networking reception
Location: Anaheim Hilton, Anaheim, CA
Those interested in attending at no cost can register at www.dyadem.com/email/mdm.html :
or contact James McDermott at (416) 312-0829.
Dyadem will be exhibiting at MD&M West at booth #668 in the Quality Pavilion.
About Dyadem
Dyadem is the market leader in 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 & Gas, Chemical, Mining, Pharmaceutical, Medical, Automotive, Electronics and Aerospace and Defense industries.
For more information, visit www.dyadem.com :
DyademMaureen Robusto, 978-289-7752
mrobusto@dyadem.com : mailto:mrobusto@dyadem.com
