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Anna Söderlund, CEO of Calmark Sweden AB (publ) has today signed the `Declaration of Conformity' showing that Calmark has adapted the quality system and the technical documentation to comply with the new IVDR regulations. The documentation will now be sent to the Swedish Medical Products Agency. Compliance with the IVDR is a requirement to maintain the CE marking of existing products from May 26, 2022 onwards.
"It has been extensive work to adapt our operations and our entire quality system to comply with the new regulations," says Anna Söderlund, CEO of Calmark. "I am very proud that we completed this in advance of the deadline. Each individual document has been reviewed and I would especially like to thank our QA team, Michael Lundh and Annika Kaisdotter-Andersson for their fantastic efforts!"
Every care has been taken in the translation of this document. In the event of discrepancies, the Swedish original will supersede the English translation.