Sonora Medical Systems Achieves ISO 17025

Misonix, Inc., a developer of minimally invasive ultrasonic medical device technology, which in Europe is used for the ablation of tumors and worldwide for other acute health conditions, announced today that its subsidiary, Sonora Medical Systems, Inc. ("Sonora"), one of the world's leading suppliers of after market products, training, depot-level repair and support services, and test equipment to the medical imaging market, announced it has achieved ISO 17025 accreditation for its Acoustic Power Testing Laboratory. Acoustic power testing is a requirement for ultrasound system and probe manufacturers to obtain FDA 510(k) clearance of their products, as well as meet the International IEC60601 standards. In addition to the important foundation of a quality management system, the ISO 17025 standard specifically addresses the technical competence of the laboratory staff, the validity and appropriateness of the test methods, traceability of measurements to national standards, appropriate application of measurement uncertainty, suitability of test equipment and environment, and the quality of the test results and reports. Test data from ISO 17025 accredited laboratories is more readily accepted by worldwide regulatory and safety organizations, reducing cost and time to market globally for manufacturers.

Misonix, Inc., a developer of minimally invasive ultrasonic medical device technology, which in Europe is used for the ablation of tumors and worldwide for other acute health conditions, announced today that its subsidiary, Sonora Medical Systems, Inc. ("Sonora"), one of the world's leading suppliers of after market products, training, depot-level repair and support services, and test equipment to the medical imaging market, announced it has achieved ISO 17025 accreditation for its Acoustic Power Testing Laboratory. Acoustic power testing is a requirement for ultrasound system and probe manufacturers to obtain FDA 510(k) clearance of their products, as well as meet the International IEC60601 standards. In addition to the important foundation of a quality management system, the ISO 17025 standard specifically addresses the technical competence of the laboratory staff, the validity and appropriateness of the test methods, traceability of measurements to national standards, appropriate application of measurement uncertainty, suitability of test equipment and environment, and the quality of the test results and reports. Test data from ISO 17025 accredited laboratories is more readily accepted by worldwide regulatory and safety organizations, reducing cost and time to market globally for manufacturers.

Michael A. McManus, Jr., President and CEO of Misonix says, "This is one more validation of the ability of our employees at Sonora to develop new important acoustic power testing capability that is recognized by regulatory bodies as a high standard of accuracy and testing. Sonora performs more acoustic power testing for companies that design and develop diagnostic ultrasound systems than anyone in the world."

"We are very proud of the professionalism of our Sonora employees. Achieving ISO 17025 accreditation further underscores our commitment to our valued customers on a world-wide basis that we will continue to improve and expand our testing facility and capabilities," says G. Wayne Moore, President and CEO of Sonora Medical Systems. "Accreditation allows customers to make informed decisions when selecting a test laboratory. It demonstrates competence, impartiality, capability, and substantiates the credibility of test results. Sonora Medical Systems is proud to offer this important new level of service to our acoustic power test customers," Moore continued.

In addition to offering industry unique ultrasound test devices and support service, Sonora Medical Systems is one of the largest and fastest growing ultrasound and MRI depot-level repair company in the United States. All Sonora operations are certified to the ISO9001 and 13485 quality standards.

For additional information concerning Sonora's Acoustic Power Testing and API products go to www.4Sonora.com.

Get curated news on YOUR industry.

Enter your email to receive our newsletters.
Loading...