Wavecare has achieved a significant milestone by obtaining ISO and CE certification for their Wavecare Software 3.0.
These certifications indicate that the software complies with the relevant requirements set by the ISO and CE standards. Wavecare has received a unique code associated with these certifications. The next step in the process involves the Danish Medicines Agency reviewing the software’s classification as medical equipment.
Achieving ISO and CE certification involves a compliance assessment process where Wavecare evaluates the software’s conformity with applicable requirements. This process ensures that the software meets the necessary quality, safety, and compliance standards.
The achievement of these certifications is due to the dedicated efforts of Wavecare’s engineer, Andreas Hertz Jensen, who has tirelessly worked on this project for over a year.
By achieving these standards, Wavecare aims to establish new benchmarks for ambitious interventions in international healthcare. This certification underscores Wavecare’s commitment to delivering high-quality software solutions in compliance with healthcare industry regulations.