PreciPoint receives ISO 13485 certification

PreciPoint has been certified according to ISO 13485:2016 after auditing by TÜV Süd.

This seal certifies that the company's all relevant business processes meet the regulatory requirements as a developer and manufacturer for medical devices. PreciPoint specialises in digitisation solutions in the field of microscopy. 

The company manufactures solutions for the digitisation of microscopy and laboratory processes for applications in medicine, research, and education. PreciPoint already collaborates with many pathologies in Germany in the development of its products. In these projects, 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 presents the iO:M8 ROSE, a solution for the digitisation 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.

Weiss added: "Together with our employees, we have reached an important milestone of which we can be very proud.”