TRIMEDX Nabs ISO 13485 Recertification
TRIMEDX has been recertified with ISO 13485, valid through August 2027, ensuring compliance with medical device quality management standards.
Category: ISO Certification
ISO Certification
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Techmer PM Get ISO 13485 Certification
Techmer PM has added ISO 13485:2016 certification for medical device and quality management systems at its site in Batavia, Illinois.
ISO Certification
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nanoComposix Completes ISO 13485:2016 Certification for Quality Management System
San Diego-based nanoComposix announces the expansion of its quality management system to include ISO 13485:2016 certification.
ISO Certification
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TRIMEDX Nabs ISO 13485 Recertification
TRIMEDX has been recertified with ISO 13485, valid through August 2027, ensuring compliance with medical device quality management standards.
Renovo Solutions Achieves ISO 9001:2015 Certification
Irvine, Calif.-based Renovo Solutions announces that it has recently achieved ISO 9001:2015 certification in clinical engineering for management of healthcare technology services for customer-specific medical equipment services.
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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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Organ Transport System Provider Paragonix Technologies Earns ISO Certification
Paragonix earned the certification for its quality management system. The company’s organ transport product portfolio combines innovative cooling technology with safe, consistent methods for cold ischemic storage and delivery for implantation.
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Medical Devices Provider Richardson Healthcare Awarded ISO Certification
The company offers a wide variety of diagnostic imaging components, systems, and replacement parts, as well as robust in-house manufacturing capabilities, plus CT service training, installation support, maintenance, troubleshooting, calibration, and conformance.
