PolarCool AB Nears MDSAP Certification Milestone
PolarCool AB is on the brink of a major breakthrough with its recent completion of the final stage 2 audit in the MDSAP process.
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PolarCool AB has completed the final stage 2 audit in the MDSAP process, paving the way for product approval in Canada by 2026.
The med-tech company PolarCool AB (publ.) has successfully navigated the final stage 2 audit in its Medical Device Single Audit Program (MDSAP) process, marking a pivotal moment in its expansion strategy. The completion of this audit signifies a crucial step toward receiving the MDSAP certification, which will enable the company to market and sell its products in new markets beyond Europe.
With the MDSAP certification, PolarCool will be poised to enter the Canadian market, a strategic move that aligns with the company’s goal of securing Health Canada product approval for PolarCap® by the second quarter of 2026. This certification simplifies the process of entering new regions by requiring only product-specific approval, a significant advantage for PolarCool as it seeks to broaden its international footprint.
Erik Andersson, CEO of PolarCool AB, expressed optimism about the progress, stating, 'Completing the final audit means that we are one step closer to obtaining our own MDSAP certificate. The audit response from Intertek has been positive, and we now look forward to completing the final actions required to receive the certificate and then, as soon as possible, submit an application to Health Canada for product approval in the Canadian market for PolarCap®.'
The completion of this audit and the anticipated MDSAP certification could be a game-changer for PolarCool, enhancing its competitiveness and opening up new revenue streams. Investors should consider the potential for growth as the company expands into new markets. However, with the final approval expected in 2026, the timeline for these developments is relatively long-term.
Given the positive trajectory and the strategic importance of the MDSAP certification, investors might consider holding their positions in PolarCool. The company’s proactive approach to regulatory compliance and market expansion could yield significant returns once the certification is secured and new markets are penetrated.
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PolarCool AB, ett medicinteknikföretag, har framgångsrikt slutfört den sista fasen av sin MDSAP-granskning (Medical Device Single Audit Program). Slutgiltigt godkännande förväntas i början av 2026, vilket möjliggör ansökan om produktgodkännande för PolarCap® i Kanada. Med MDSAP-certifieringen kan PolarCool marknadsföra och sälja sina produkter på fler marknader utanför Europa, där endast produktspecifikt godkännande krävs för varje ny region. PolarCool prioriterar Kanada med målet att få Health Canadas produktgodkännande för PolarCap® under andra kvartalet 2026. Företaget har tidigare meddelat att man framgångsrikt avslutat den första fasen av certifieringsprocessen och nu även den andra och sista revisionen. VD Erik Andersson uttrycker att avslutandet av den sista revisionen är ett viktigt steg mot att erhålla MDSAP-certifikatet och ser fram emot att ansöka om produktgodkännande i Kanada.
