Longmont, Colo.-based Acertara Acoustic Laboratories announces that it has received the latest version of accreditation from the American National Standards Institute National Accreditation Board for ISO/IEC 17025:2017 for ultrasound acoustic testing and calibration.
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.
Last week, Salem, Va-based First Call Parts Inc. received ISO 9001:2015 certification for the breakdown of diagnostic imaging systems and repair, refurbishment, and testing of imaging system parts. Such certification signifies that First Call Parts has a quality management system that has been audited by a third party and deemed able to consistently provide a product that meets all requirements of interested parties.
Appleton, Wis.-based Technical Prospects announced that it has achieved International Organization for Standardization (ISO) 9001:2015 certification. The company, which recently celebrated 20 years of operation, specializes in Siemens medical imaging equipment.
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Charleston, S.C.-based Sage Services Group recently transitioned from the International Organization for Standardization (ISO) 9001:2008 standard to the ISO 9001:2015 standard. The scope of Sage’s certification includes: “Repair, Replacement Parts, Refurbished Equipment, Patient Cables and Designer of Accessories to the Medical Industry.”
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Nashville, Tenn.-based Tri-Imaging Solutions announced that it has achieved ISO 9001:2015 certification. Such certification specifies that Tri-Imaging meets or exceeds requirements for a quality management system that includes the ability to consistently provide products and services that fulfill statutory and regulatory requirements.
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Performance Review Institute (PRI) Registrar has recognized Trisonics for meeting the ISO 9001:2008 standard, which specifies requirements for a quality management system. To achieve this certification, an organization must demonstrate an ongoing ability to meet customer and applicable statutory and regulatory requirements.
Read MoreOn January 28, Consensys Imaging Service (formerly Unisyn) announced it has received certification to ISO 9001:2008 and ISO 13485:2003 international quality standards. The announcement comes 9 months after the sale of Unisyn’s probe repair and parts business to GE Healthcare.
Read MoreCalyx Metrology Laboratory President John A. Walls III posted a suggestion regarding quality on the Biomedtalk listserv, saying: “I suggest departmental accreditation is really the quality benchmark that the world’s professional biomedical
Read MoreAcertara Acoustic Laboratories, Longmont, Colo, announced on October 1, 2013, that its quality management system has been awarded both ISO 9001:2008 and ISO 13485:2003 certifications through Orion Registrar Inc.
Read MoreISO has released a new standard for organizations of all sizes, types, and activities that provides a framework for getting the best out of people in the implementation of a quality management system based on ISO 9001.
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Battery load and service tool, digital oscilloscope, RFID-enabled
Read MoreThe RABQSA International Inc medical devices competency unit has been created for individuals wishing either to become trained to audit to the ISO 13485 standard.
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Multi-product calibrator, RTLS for RFID and bar code labels, electrical medical safety analyzer, 4D transducer repair
Read MoreThe Association for the Advancement of Medical Instrumentation adopts ISO 8638 and ISO 8637 standards.
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