For us, the certification of our quality management system according to ISO 13485:2016 was only the first step. After receiving the certificate, the work for us did not stop at all, but rather it has only just begun.
tuomi has implemented a Quality Management System based on ISO 13485:2016. It has some unique challenges to live QMS in an owner-managed company. Long-established processes are questioned and potentially improved.
QuDoc, the secure data management system from tuomi, meets all the requirements of the MDR and GDPR. It is the perfect tool for managing documentation in accordance with the Medical Devices Regulation.