PreciPoint GmbH successfully certified according to ISO 13485 TÜV Süd confirms quality management system for medical devices

Freising – Seal of quality for medical technology: after successful auditing by TÜV Süd, PreciPoint GmbH, which specializes in digitization solutions in the field of microscopy, has been officially certified according to ISO 13485:2016 since June 2022. This seal certifies that the company’s all relevant business processes meet the regulatory requirements as a developer and manufacturer for medical devices. PreciPoint manufactures solutions for the digitization of microscopy and laboratory processes for applications in medicine, research and education. The company already collaborates with many prestigious pathologies in Germany in the development of its products. In these projects, promising approaches in the treatment of numerous cancers are being advanced, while at the same time the devices are being developed that make these research results visible and at the same time simplify laboratory processes. PreciPoint’s devices must be easy and fast to operate, while at the same time meeting the highest scientific standards. In 2022, PreciPoint will present the iO:M8 ROSE, a distinctive solution for the digitization of intra-operative examinations in cancer surgery. These examinations, in which pathologists determine during surgery whether sufficient material has been removed from the patient’s body and whether the edges of the operated site are free of cancer cells, are traditionally performed in a time- and place-bound manner using classical light microscopy. PreciPoint’s microscopy solutions enable digital ways of working, allowing significant cost savings and faster data exchange among specialists. “In view of the ever-increasing shortage of pathologic specialists and the simultaneous rise in cancer cases in Germany, Europe and worldwide, solutions like ours are essential,” explains Dominik Gerber, who heads the company together with Nicolas Weiss. With the ISO 13485:2016 certification, another requirement has been met to make PreciPoint’s products accessible to a wider range of customers in the medical field. “Together with our employees, we have reached an important milestone of which we can be very proud,” says Nicolas Weiss.