Medical-Device Manufacturer Hobson & Motzer Earns ISO 13485 CertificationNovember 25, 2020
Durham, CT-based Hobson & Motzer has earned ISO 13485 certification, recognizing that its quality-management system (QMS) enables it to provide medical devices and related services that consistently meet customer and regulatory requirements. The firm is a vertically integrated manufacturer of precision metal components and assemblies, deploying the precision metal stamping, coining, CNC machining and precision electrochemical machining processes.
Companies with ISO 13485 certification exhibit a commitment to the medical-device industry and to patients around the world who benefit from their critical products. ISO 13485 is designed to be used by organizations involved in one or more stages of the medical-device lifecycle: design and development, production, and storage. The framework for implementation includes outlining how to review and improve processes; increasing efficiency, cutting costs, and monitoring performance; demonstrating the production of safer medical devices; and meeting regulatory requirements and customer expectations.
Notes Hobson & Motzer president Bruce Dworak: "Although we already were producing at a very high standard, 13485 aligns better with our core business focus in the medica-device space. After a five-day onsite audit, neither of our auditors reported any findings, a testament to our strong commitment to quality, our people and a robust QMS.”
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