Kapelan Bio-Imaging GmbH is a developer and distributor of software solutions for digital image analysis in laboratory diagnostics based in Leipzig, Germany. The software is used in scientific and medical research as well as in clinical laboratory routine or in the pharmaceutical industry and is marketed worldwide. However, increasingly complex global networking of different players in the laboratory routine inevitably leads to increased requirements for internationally valid certifications for companies in this industry. The processes of laboratory diagnostics must not only be of high quality, but above all must comply with globally valid standards in order to be equally transparent and reproducible. To ensure that Kapelan Bio-Imaging can demonstrably meet these requirements, the company has been working on the implementation of the new quality management system (QMS) since February 2021. It was successfully implemented in the same year, enabling the company to start working with the new QMS in November 2021. The focus of this system is to increase the quality of the software produced by Kapelan Bio-Imaging. It is achieved through a wide range of measures, from software development optimization to testing, release and maintenance. Although these processes have already been implemented to a large extent in line with the requirements of ISO 13485, this implementation is now being carried out much more stringently as part of the company’s own quality management system. In the course of an audit, a customer from the regulated pharmaceutical environment noted that the processes had already been running transparently and validly to date and that they largely met the requirements of ISO 13485. Nevertheless, official verification is essential in order to meet the requirements of Kapelan Bio-Imaging’s target markets. On march 9th 2022, the certification audit was successfully completed in this regard.
The ISO 13485 certification provides Kapelan Bio-Imaging with definitive proof that all processes and products meet the current international standards for medical devices in terms of quality. In addition, CEO Olaf Brenn sees an opportunity to expand the company’s reach through this proof. “We are pleased with the successful completion of the certification audit. As a result, we see ourselves in a good position to develop new target groups.”
