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News

Dyadem supports DiaSorin to improve risk assessment of its medical devices

Dyadem : 13 May, 2008  (Application Story)
DiaSorin has selected Dyadem to improve its risk assessment and ensure the quality of its medical devices by using Dyadem’s FMEA-Med software to improve its risk assessment processes and ensure regulatory compliance.
FMEA-Med is a software solution that delivers Failure Mode and Effects Analysis (FMEA) for medical devices and pharmaceutical manufacturers.

DiaSorin selected FMEA-Med to improve product designs analysis for defects, and to optimise manufacturing processes by creating consistent quality standard templates that are used throughout the company's headquarters in Italy and facilities in Germany and the United States. These templates bring a unified methodology to DiaSorin's worldwide processes and standardize risk management.

The global scale of DiaSorin's operations require the company to comply with a host of domestic and international quality regulations, including the IVD Directive, CE Marking, ISO 14971 and various Food and Drug Administration requirements in the United States. These regulations require documentation of risk assessment procedures and monitor the quality of incoming medical devices. For example, the FDA requires the inspection of foreign medical supply facilities before their products are sold in the United States.

DiaSorin's facilities operate independently from each other, but needed a common way to assess risk and unify compliance. Individual teams are able to improve their efficiency through the use of standard Dyadem templates used across the organization. Previously, DiaSorin was using standard spreadsheet programs that allowed few customisations for medical device manufacturers. Now, DiaSorin is able to transfer knowledge and processes across facilities, allowing for easy adjustments to changes in production locations. The result is a unified approach to quality.

When evaluating potential solutions, DiaSorin used Dyadem web demonstrations to view FMEA-Med's capabilities. DiaSorin is now working with Dyadem experts on-site to deploy the software, create process templates and train staff.

'Last year alone, the US FDA issued 20 recalls of medical devices . an alarming increase compared with five years ago. DiaSorin is leading its industry in setting high standards for quality and ensuring consumer safety,' said Kevin North, president and chief executive officer of Dyadem. 'With the world's top ten medical device manufacturers on our client list, Dyadem understands the unique needs of medical device companies and the scrutiny they are under. We are working closely with our customers to ensure that medical device quality is not an afterthought. '
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