Calmark Sweden AB has today received its certificate according to ISO 13485:2016 (Medical devices — Quality management systems — Requirements for regulatory purposes). The certificate was awarded by RISE Research Institutes of Sweden AB (RISE AB), confirming that Calmark's quality management system meets the requirements for development, production, sales and distribution of in vitro diagnostic products (IVD). The new ISO certificate is valid as of December 9th, 2020, until December 8th, 2023.
ISO 13485:2016 is an internationally recognized standard that is aligned with regulatory requirements for the development of medical devices in Europe and other regulatory jurisdictions. Full compliance to the standard is not currently required for Calmark's products but will in the near future be mandatory under the new in vitro diagnostic medical device regulations (IVDR).
"The certification is an important step towards IVDR and puts us in a significantly better position to launch in the rest of the world," says Michael Lundh, Quality Assurance and Regulatory Affairs Director. "The certification proves that we have the regulatory aspects in place and a quality management system that works. It is very gratifying to see this confirmed by an objective and independent audit."
"The certification of the quality management system is an important cornerstone of our business development," says Anna Söderlund, CEO of Calmark. "I would like to extend my thanks to Michael Lundh in particular, for the sterling work he has done in ensuring the structure and the processes."
Every care has been taken in the translation of this document. In the event of discrepancies, the Swedish original will supersede the English translation.