Diagnostic company SphingoTec has been successfully re-certified according to ISO 13485 and received its first IVDR certificate for its IVD product sphingotest® penKid®. The certificates awarded by its Notified Body TÜV SÜD Product Service GmbH demonstrate the commitment of SphingoTec to meet the high-quality requirements of the ISO 13485 and the (EU) 2017/746 (IVDR).

The IVDR-compliant and CE IVD-released product sphingotest® penKid® is used as an aid in the diagnosis of kidney injury in patients with sepsis or septic shock and meets the regulatory requirements to ensure the safety of critically ill patients to the utmost extent possible.

Dr. Angelo Moesslang, Managing Director and CFO of SphingoTec commented, “Ensuring compliance in all aspects of our clinical biomarker validation processes is an absolute requirement for our company and our licensing partners. This includes robust quality management, setting up and maintaining technical documentation, continuous biomarker evaluation, and diligent manufacturing of products. By maintaining these quality standards, we are able to offer our partners valuable business opportunities and a strong competitive advantage in the marketplace.”

As a company committed to innovation in the field of diagnostic testing, SphingoTec plans to continue collaborating with official regulatory bodies in the future to certify further products and expand existing certifications. By building up on the success with sphingotest® penKid®, SphingoTec aims to lead the way in developing diagnostic tools that meet the highest standards of quality, safety, and regulatory compliance.

Source: Company Press Release