Medotec

Medotec is a Swedish medical-device consultancy focused on clinical regulatory evidence. It supports manufacturers and other industry stakeholders with MDR and IVDR documentation and conformity-assessment work. Its services concentrate on clinical evaluation and post-market monitoring, including intended-use review, risk analysis, clinical evaluation plans and reports, clinical investigations, post-market plans and periodic safety update reports. The consultancy combines engineering, clinical healthcare and clinical-research expertise.