PreciPoint Iso zertifiziert

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

Nicolas Weiss

Nicolas Weiss

Managing Director at PreciPoint

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.

About PreciPoint

PreciPoint specializes in the development, production and marketing of innovative digitization solutions and photonics systems in the field of microscopy. Its product portfolio includes the M8, O8 and FRITZ microscopes. These fully motorized transmitted light microscopes operate digitally and without an eyepiece. They produce high-resolution images of specimens. The microscopes impress with their ease of operation and compact design. They can also be operated from any location thanks to the remote function. PreciPoint offers versatile software applications with which the images can be visualized, processed and analyzed. The PreciCloud platform enables new working models between experts. Based in Freising, Germany, PreciPoint is an ISO 13485 certified medical technology company and one of the top startups in Germany. The company has won various awards, including 3rd place as a Top 100 Innovator 2022. In addition, PreciPoint received awards as an employer in 2021 as well as 2022, for example, as a Top Startup Employer in the healthcare sector by two independent juries.

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