TORONTO, May 12 DiaSorin, a global provider of clinicalin-vitro diagnostic medical devices, has turned to Dyadem to improve its riskassessment and ensure the quality of its medical devices. Dyadem, a leader inQuality Lifecycle Management and Risk Lifecycle Management solutions, isassisting DiaSorin through the use of its FMEA-Med software to improve itsrisk assessment processes and ensure regulatory compliance.
FMEA-Med is a software solution that delivers Failure Mode and EffectsAnalysis (FMEA) for medical devices and pharmaceutical manufacturers. Dyademsolutions improve quality and prevent potential flaws in hardware design,manufacturing and processes in a variety of industries, including aerospace,chemical and automotive. DiaSorin selected FMEA-Med to improve productdesigns analysis for defects, and to optimize manufacturing processes bycreating consistent quality standard templates that are used throughout thecompany's headquarters in Italy and facilities in Germany and the UnitedStates. These templates bring a unified methodology to DiaSorin's worldwideprocesses and standardize risk management.
The global scale of DiaSorin's operations require the company to complywith a host of domestic and international quality regulations, including theIVD Directive, CE Marking, ISO 14971 and various Food and Drug Administrationrequirements in the United States. These regulations require documentation ofrisk assessment procedures and monitor the quality of incoming medicaldevices. For example, the FDA requires the inspection of foreign medicalsupply facilities before their products are sold in the United States.
DiaSorin's facilities operate independently from each other, but needed acommon way to assess risk and unify compliance. Individual teams are able toimprove their efficiency through the use of standard Dyadem templates usedacross the organization. Previously, DiaSorin was using standard spreadsheetprograms that allowed few customizations 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 resultis a unified approach to quality.
When evaluating potential solutions, DiaSorin used Dyadem Webdemonstrations to view FMEA-Med's capabilities. DiaSorin is now working withDyadem experts on-site to deploy the software, create process templates andtrain staff.
"Last year alone, the U.S. FDA issued 20 recalls of medical devices . analarming increase compared with five years ago. DiaSorin is leading itsindustry in setting high standards for quality and ensuring consumer safety,"said Kevin North, president and CEO of Dyadem. "With the world's top tenmedical device manufacturers on our client list, Dyadem understands the uniqueneeds of medical device companies and the scrutiny they are under. We areworking closely with our customers to ensure that medical device quality isnot an afterthought. "
Founded in 1993, Dyadem is the market leader in Quality LifecycleManagement and Risk Lifecycle Management solutions. Dyadem provides softwareand services that empower companies to manage quality, mitigate risks, achieveregulatory compliance, plan for business continuity and improve profitability.Dyadem works with 85% of the Fortune 500 companies and serves the high tech &electronics, medical devices, oil and gas, chemical, automotive,pharmaceutical and aerospace and defense industries. For more information,visit www.dyadem.comFor further information, contact: Dyadem Ltd Angela Schwecke 905.762.5243 [email protected]
Text 100 Public Relations Greg Sabey 617.399.4909 [email protected]