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.
The provider of AI-enabled medical imaging software is now certified under ISO/IEC 42001:2023 for responsible AI management.
Eitan Medical earned International Organization for Standardization (ISO) 14001 certification for production of its range of medical devices.
MESI, Ltd., has successfully added the certificate for conformance with ISO 13485:2016/MDSAP to its array of international certifications, including EC and FDA.
The provider of AI-enabled medical imaging software is now certified under ISO/IEC 42001:2023 for responsible AI management.
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.
Read MoreDoral, 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.
Read MoreIrvine, 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.
Read MoreHarrisburg, 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.
Read MoreLongmont, 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.
Read MoreIn 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.
Read MoreTomball, 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.