Subtle Medical Certified Under First International AI Management Standard
The provider of AI-enabled medical imaging software is now certified under ISO/IEC 42001:2023 for responsible AI management.
Category: ISO Certification
ISO Certification
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ISO Certification
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Eitan Medical Receives ISO 14001 Environmental Management Certification
Eitan Medical earned International Organization for Standardization (ISO) 14001 certification for production of its range of medical devices.
ISO Certification
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MESI, Ltd. Earns MDSAP Certification
MESI, Ltd., has successfully added the certificate for conformance with ISO 13485:2016/MDSAP to its array of international certifications, including EC and FDA.
ISO Certification
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Subtle Medical Certified Under First International AI Management Standard
The provider of AI-enabled medical imaging software is now certified under ISO/IEC 42001:2023 for responsible AI management.
Tri-Imaging Solutions Achieves ISO 13485:2016
Madison, Tenn.-based Tri-Imaging Solutions announces that it has received ISO 13485:2016 certification from registrar Orion for its imaging parts, equipment, and training services.
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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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ISO Certification
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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.
