Category: ISO Certification

ISO Certification

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TRIMEDX Awarded ISO Certification for Medical Device Quality Management System

TRIMEDX, Indianapolis, announces that it has been awarded the International Organization for Standardization’s Medical Device Quality Management System (MD QMS) certification ISO 13485:2016, which outlines best practices in developing an effective MD QMS that covers the safety and quality of medical devices throughout their lifecycle.

Trisonics Achieves ISO 13485 Certification

Harrisburg, Pa.-based Trisonics Inc., a company specializing in diagnostic ultrasound equipment, announces that it has earned ISO 13485 certification. The comprehensive system audits cover every aspect of Trisonics operations, according to company officials.

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Acertara Upgrades ISO 13485:2016 Certification

Longmont, Colo.-based Acertara, a privately-held ultrasound engineering, test product development, and advanced probe repair company, announced that it has achieved ISO 13485:2016 certification for medical device and quality management systems, upgraded from the ISO 13485:2003 certificate.

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ISO Certification

Latest

ivWatch Receives CE Mark and ISO 13485:2016 Certification

In addition to conforming to European standards as signified by the CE mark, the company also announced that it has obtained ISO 13485:2016 certification through the Medical Device Single Audit Program, a global standard for medical device quality management systems.