Medical Equipment Doctor Earns ISO 13485 Certification
Certification underscores the company’s adherence to international quality standards for medical device repair and refurbishment.
Category: ISO Certification
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ISO Certification
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Greenlight Guru Earns ISO 9001 and ISO 27001 Certifications
Greenlight Guru, developer of the MedTech Lifecycle Excellence Platform, is now certified for both ISO 9001Â and ISO 27001.
ISO Certification
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3D LifePrints Achieves ISO 13485:2016 Certification
The certification enables 3D LifePrints to expand its point-of-care model by launching a new range of patient-specific sterilizable surgical guides and anatomical models, while continuing to deliver its existing custom-made medical devices.
ISO Certification
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Medical Equipment Doctor Earns ISO 13485 Certification
Certification underscores the company’s adherence to international quality standards for medical device repair and refurbishment.
MedEquip Biomedical Achieves ISO 13485:2016 Certification
Doral, Fla.-based MedEquip Biomedical announces that it has successfully converted from ISO 9001:2008 standards and has received ISO 13485:2016 certification from NSF International Strategic Registration.
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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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ISO Certification
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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.
