An amazing end of the intense week and the challenging last months overall.
Cardiolyse has successfully finished the stage 2 audit for ISO 13485 and CE as a medical software certification.
CE is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area.
CE is essential to fully enter the EU digital healthcare market and proceed with commercial partnerships there.
The independent auditors from TUV Rheinland have reviewed our software as well as all the technical documentation needed to pass the CE marking process.
Cardiolyse’s ECG analyzing algorithms are now going to be reviewed by the clinical experts, which is the last stage in the decision-making process about issuing the certificate.
Congratulations to all the amazing team!
Great things take time, but now we are one step closer to our next exciting achievement.