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156 Case Studies
Case Study: TraTek streamlines ISO 13485 compliance with BSI Entropy
A BSI Case Study
How TraTek Benefits From Entropy
TraTek, a precision manufacturer of orthopaedic surgery screws, plates, and instruments, needed a better way to manage the large volume of records required for ISO 13485 compliance. The company wanted to move away from paper-based quality management, improve access to records across its Indiana and Costa Rica facilities, and reduce IT overhead by using a hosted system. BSI’s Entropy QMS was selected to help meet these needs.
BSI implemented Entropy as TraTek’s central, web-based quality and compliance platform, providing secure role-based access, automated workflows, document control, reporting, and audit support. The solution helped TraTek streamline audits, speed up revisions to control documents, improve record keeping, and operate more efficiently overall. According to TraTek, Entropy delivered a positive return on investment and scaled well with the company’s growth.
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TraTek
Luke Bulino
General Manager