Sonora Medical Systems, an after-market test equipment supplier, has created a testing accreditation program for its FirstCall system directed toward non-hospital based technical support entities.
The launch of the program follows a recent warning from the supplier that at least one third-party ultrasound service company illegally modified its FirstCall probe testing software.
In keeping with Sonora’s ISO9001/13485 quality system, all participants in the FirstCall user accreditation process will be site audited by Sonora and will agree to develop and maintain an internal quality system consistent and in compliance with several of the relevant elements of ISO9001/13485. In addition there will be annual and ongoing quality system surveillance audits by Sonora.
The Longmont, Colo.-based Sonora said that accredited users will also be licensed to create additional probe files for their FirstCall units and have them validated by its research and development group in compliance with regulatory requirements before use.