Stockholm, November 11, 2020: Capitainer AB, a medtech company committed to making Dried Blood Spot testing universal, is pleased to announce that the company has received the International Organization for Standards (ISO) 13485:2016 certification for its Quality Management System (QMS).
Capitainer’s certification is issued by Lloyds Registar, one of the world’s leading providers of business certification, verification, audit, and training courses. ISO 13485 is designed specifically for medical device companies and commonly regarded as essential for accessing international markets. It comes as Capitainer enters a period of rapid expansion following the signing of key distribution agreements in the US and Europe for its highly accurate qDBS dried blood spot sampling system. Interest is strong across a wide range of challenging applications from therapeutic drug monitoring, genomics anti-doping testing to COVID-19 testing.
Christopher Aulin, CEO of Capitainer commented: “We are delighted to have attained ISO 13485 for our Quality Management System. We are committed to developing the highest quality products at Capitainer and our team has worked hard to achieve this milestone. Both the FDA and EU require a quality system and this award will accelerate commercialisation.”
Capitainer’s qDBS system is designed to enable patients to collect their own volume defined dried blood spot at home. The patented smart chip ensures precise sample volumes of 10ul with low CV, independent of haematocrit. Patients simply place their finger over the inlet port on the qDBS card which automatically fills a microchannel with the required amount and discards any excess. The potential for human error is thus completely eliminated. Subsequently, the blood volume contained in the microchannel automatically transfers to the specimen collection membrane, forming an accurate and high-quality dried blood spot sample, preserved for quantitative bioanalysis. The filled card can then be safely transported to the point of testing without the need for refrigeration or specialised packaging.