TORONTO, June 5 /PRNewswire/ -- Genzyme Corporation (Nasdaq: GENZ), one of the world's leading biotechnology companies, is enhancing the quality of the medical devices produced in its Bio-surgery division with software from Dyadem, the leader in Risk Lifecycle Management and Quality Lifecycle Management. Dyadem's FMEA-Med, a software solution that helps automate compliance reporting, enables Genzyme to link risk and quality, and to set a new standard in quality throughout the lifecycle of its biotherapeutic and biomaterial products. Genzyme's leading biomaterials and cell therapies reduce the time and complications associated with surgery, and in some cases, postpone the need for surgery.
FMEA-Med is a software solution that delivers industry-standard Failure Mode and Effects Analysis (FMEA) reports for medical devices and pharmaceutical manufacturers. FMEA methodology maintains quality and prevents potential flaws in hardware design, manufacturing and processes in a variety of industries, including pharmaceutical, automotive, and high-tech and electronics. Dyadem's FMEA-Med focuses on the entire quality lifecycle management process, which is essential to the research and advancement of these fields. The medical device industry must comply with FDA and ISO standards among others.
With more than 300 employees spanning three sites in the United States, Genzyme's Bio-surgery division now has a single standard for risk assessment. As these multiple sites are subject to varying government and industry regulatory standards, Genzyme's use of FMEA-Med creates a consistent quality standard across the division to fulfill the varying requirements.
Prior to selecting Dyadem, Genzyme used manual templates for FMEA
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