Category: ISO Certification

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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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.

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FOBI Medical Attains ISO 13485:2016 Certification

Tomball, Texas-based FOBI Medical, FiberOptic Bulbs (FOBI) announced that it has received International Standardization Organization’s ISO 13485:2016 certification, indicating the company’s quality management system for medical lamps and fiber optic cables adheres to stringent requirements.

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ISO Certification


Cultivating a Culture of Quality: Rick Lytle

In late November, Milwaukee-based Alpha Source acquired BC Technical, doubling the size of the former company. Here, Alpha Source CEO Rick Lytle discusses what the merger means for the healthcare industry and advises HTM professionals about what to look for when selecting a service provider.