Kapelan Bio-Imaging has successfully passed the ISO 13485 audit for medical devices After the initial audit of the quality management system according to ISO 13485 in March 2022, Kapelan Bio-Imaging…
Category: Company
Certificate for ISO 13485 granted
Kapelan Bio-Imaging is certified supplier according to ISO 13485 for medical devices
After successfully completing all inspections, Kapelan Bio-Imaging received the ISO 13485 certificate by beginning of June 2022. From now on, the developer and distributor of software solutions for digital image analysis in laboratory diagnostics demonstrably complies with the highest international standards in this sector. The fulfillment of these requirements is essential in order to be able to maintain its position on the international stage of scientific and medical research, clinical laboratory routine and the pharmaceutical industry. The certificate guarantees an optimal flow of all processes from software development to testing and release up to maintenance. Furthermore it ensures the highest possible transparency. The certification audit was already completed at the beginning of March 2022. The complete process from the beginning of the implementation of the new quality management system to the certificate took about 16 months. During this period, the existing processes, which were already running with above-average transparency and validity, were further optimized and improvements were stringently implemented so that they now demonstrably and comprehensively meet all requirements of ISO 13485.
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