In recent years, Tecan has successfully embarked on a program to achieve ISO certification for all its global manufacturing and sales organizations, and now the Tecan Group parent company has been certified to ISO 13485 standard for its web-based management system.
Tecan's Regulatory Affairs (RA) team has invested in a new market intelligence infrastructure that will keep our product development teams, business units and worldwide sales organizations, as well as our customers, fully up-to-date with regulatory information as it changes.
A recent article in the January 2008 issue of Qualität und Zuverlässigkeit (Quality and Reliability), the most widely read quality journal in German speaking countries, described a new quality management approach with a radically different organizational structure.
For companies planning to produce new products designed specifically for the clinical diagnostics market, successful product development is only part of the challenge. Our expertise in quality and regulatory issues, as well as years of experience in providing instruments to diagnostics laboratories, puts Tecan in a unique position to help you take your application from the life science market to the clinical/IVD market, or to take your existing clinical diagnostics products into new geographical areas.