Zetta Medical Technologies announces ISO 13485:2016 certification
April 18, 2018
Lake Zurich, IL April 18, 2018 — Zetta Medical Technologies LLC, the most technically advanced medical imaging independent service organization, announced today that the company has received its ISO 13485:2016 certification.
Zetta’s ISO 13485:2016 Quality Management System complies with the requirements for an independent service organization for the servicing, installation, de-installation and sales of medical imaging equipment and parts; and the design, development, production, installation, sales and servicing of medical imaging related software.
ISO 13485 is an International Standard Organization quality management system specifically developed for medical devices. Its primary objective is to facilitate harmonized medical device regulatory requirements. The standard contains specific requirements for manufacture, installation and servicing and calls for:
• Implementation of a Quality Management System with several enhancements
• Risk Management approach to product development and product realization
• Validation of processes
• Compliance with statutory and regulatory requirements
• Effective product traceability and recall systems.
Kelly Gargano, Director of Business Operations and Zetta’s Quality Management Rep stated: “Zetta’s certification process included updating our existing quality management system to ISO 13485 compliance, enhancing our management review system, internal auditing and a certification audit which was very successful as no non-conformances were identified.”
In achieving compliance with the standard requirements, Zetta choose NQA, USA, one of the largest and most respected certification bodies in the world, with over 35,000 certifications in over 70 countries. NQA, USA reviewed our management system and provided Zetta its ISO 13485:2016 certification.
Mike Ghazal, CEO of Zetta Medical Technologies, LLC commented: “Zetta has developed and implemented our quality management system to improve our overall performance, maintain a high-level of quality customer satisfaction and to provide innovative technology solutions. Our decision to work towards ISO 13485 certification demonstrates our commitment and determination to deliver consistent products and services to our customers and continual technology development”
About Zetta Medical Technologies, LLC
Zetta is a high performance independent service organization offering preowned medical imaging equipment, dedicated CT, MRI and PET/CT service and quality replacement parts to the medical imaging industry. To distinguish itself from others, Zetta has successfully developed and manufacture its own suite of software solutions to help customers to keep their scanners current with the latest software technologies and mandates including dose reporting and enabling low dose techniques. Visit www.ZettaMed.com for more information.