Capitainer Secures International Organization for Standards...

Pharma Tech Outlook: Pharma Tech Magazine

Capitainer Secures International Organization for Standards Certification for Its Quality Management System

By Pharma Tech Outlook | Wednesday, November 18, 2020

Capitainer is awarded ISO 13485:2016 as interest grows in smart qDBS testing for COVID-19 and other challenging applications.

FREMONT, CA: Capitainer AB, a medtech company, committed to making Dried Blood Spot testing universal, receives the International Organization for Standards (ISO) 13485:2016 certification for its flagship Quality Management System (QMS). Capitainer’s certification is issued by Lloyds Registar, one of the world’s leading business certification providers, audit, verification, and training courses. ISO 13485 is developed specifically for medical device firms and commonly regarded as vital for accessing international markets. It comes as Capitainer enters a period of rapid expansion following the signing of 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.

Capitainer is delighted to have attained ISO 13485 for its Quality Management System. The company is committed to developing the highest quality products at Capitainer, and its team has worked hard to achieve this milestone. Both the FDA and the EU require a quality system, and this award will accelerate commercialization.

 Capitainers qDBS system is designed to enable patients to collect their volume defined dried blood spot at home. The patented smart chip ensures precise sample volumes of 10ul with low CV, independent of haematocrit. Patients place their finger over the inlet port on the qDBS card, which automatically fills a microchannel with the needed amount and discards excess. The ability for human error is thus completely prevented. The blood volume in the microchannel transfers to the specimen collection membrane automatically, forming an accurate and high-quality dried blood spot sample, ready for quantitative bioanalysis. The filled card can then be safely transferred to the point of testing without the need for refrigeration or specialized packaging.

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