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Kapelan Bio-Imaging Successfully Certified to ISO 13485: Quality Management Meets Legal Requirements, Qualifies Kapelan Bio-Imaging as Provider of Medical Device and IVD Software
Leipzig, Germany, 240313: Kapelan Bio-Imaging is pleased to announce that the company has successfully passed the surveillance audit for ISO 13485. This certification confirms that Kapelan Bio-Imaging’s quality management meets legal requirements and qualifies the company to provide software for medical devices and in vitro diagnostics (IVD). ISO 13485 is an internationally recognized standard […]Read More »Kapelan Bio-Imaging offers new calibration service for grayscale charts
Kapelan Bio-Imaging, a provider of innovative solutions for biomedical image analysis, proudly introduces its new grayscale chart calibration service. Customers can now have their reflected and transmitted light charts precisely calibrated to ensure optimal scanner performance. The calibration service is created as standardized procedures (SOP) that are based on the ISO 13485 quality management system. […]Read More »New PQ Extension: Ensuring Accurate Analysis of 1D Gels through Full System Validation
The PQ Extension is an advanced software tool by Kapelan Bio-Imaging that extends the capabilities of LabImage 1D. It enables users to run a full analysis system validation for any 1D gel or western blot, providing proof of analysis quality. This is a significant breakthrough as it allows users to ensure that their analysis results […]Read More »ISO 13485 certification successfully confirmed
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 has now successfully passed the surveillance audit. Kapelan Bio-Imaging is therefore still a certified provider of medical products according to ISO 13485. In addition to […]Read More »A fully automated system qualification for analysis of gels and blots
Kapelan Bio-Imaging works on a module to run complete system validation (PQ) for analysis software LabImage 1D As analyses become more and more complex, and are increasingly automated while at the same time having to comply with the highest international standards, the requirements for system validation are also becoming ever greater. For this reason, Kapelan […]Read More »