Commitment to quality and safety through regulatory compliance
Cercare Medical ApS is committed to delivering products of the highest quality and safety. We only market products in compliance with regulatory directives, and we maintain compliance by following harmonized standards such as ISO 13845:2016 for Quality Management system, ISO 14971:2012 for performing Risk Management, and EN 62304:2006+A1:2015 for software development processes and validation of software.
Cercare Medical NeuroSuite is CE marked in compliance with the European Union Council Directive 93/42/EEC.
The CE mark indicates that the product conforms to the Medical Device Directive, and lives up to the requirements set by the European Union for safety and effectiveness of medical devices.