Hemcheck Sweden AB has today received the certification according to the quality standard ISO 13485. The certificate has been issued by RISE Research Institutes of Sweden AB and is valid for the next three years. The work to specifically prepare the company for the certification began already in the previous year and the certification process has now been fully completed with a successful result. Achieving ISO 13485 certification is important because it shows that the quality management system in the company is on a high level, and can be requested to enable sales, for example when registering products in certain markets.
– I am very happy to be able to announce that Hemcheck has been certified according to ISO 13485. It is an important step in our development and shows that we have quality assured our processes within the company. I would like to extend a special thank you to everyone in the company who worked for a long time to make this possible, says Joen Averstad, CEO of Hemcheck.
For further information contact:
Hemcheck Sweden AB (publ)
Joen Averstad, CEO
Tel: +46 76 108 8191
Hemcheck Sweden AB, founded in 2010, produces and commercializes a patented CE-marked concept for point of care hemolysis detection. The concept consists of disposable tests as well as readers that can very quickly, directly upon sampling, identify hemolysed blood samples in vacuum tubes and blood gas syringes. Hemolysis, ruptured red blood cells, is the most common reason globally why blood samples cannot be analyzed accurately and is also a biomarker for acute medical conditions. Hemcheck’s goal is to contribute to improved healthcare by offering user-friendly solutions for the detection of hemolysed blood samples in direct connection with blood sampling near the patient. By doing so, Hemcheck can contribute to increased patient safety, more efficient processes and lower costs. The company is listed on the Nasdaq First North Growth Market.
FNCA Sweden AB, 08-528 00 399, info@fnca, is the Certified Adviser to the company.