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 conformity for medical products, the area of IVD (in vitro diagnostics) is an important segment for Kapelan. “The constant further development of our quality guidelines according to the quality management system leads not only to an increase in the quality of our software but also to better transparency for our customers,” explains Olaf Brenn, Managing Director of Kapelan Bio-Imaging GmbH from Leipzig.