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 specifically developed for organizations in the medical device industry. It sets requirements for a quality management system to ensure that products and services meet the stringent requirements of the medical industry.

By successfully completing the surveillance audit, Kapelan Bio-Imaging has demonstrated that the company has a robust quality infrastructure to offer high-quality software solutions for the medical field. This certification underscores Kapelan Bio-Imaging’s commitment to continuous improvement and customer satisfaction.

“We are proud to have received the ISO 13485 certification, as this marks another milestone in our commitment to providing top-notch solutions for medical imaging,” said Olaf Brenn, CEO at Kapelan Bio-Imaging. “This certification confirms our dedication to quality and safety and gives our customers confidence that they are working with a reliable partner.”