Capitainer has received the International Organization for Standards (ISO) 13485:2016 certification for its Quality Management System (QMS).
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, states the company.
“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 commercialization,” says Christopher Aulin, CEO of Capitainer.