Reorganization and strengthening of the QA&RA Area. Focusing on new MDR Certification

HMC embarking on the conversion of its medical devices from the current MDD certifications to the new MDR 2017/745 Regulation is progressing, also after the update of the official application date, postponed to May 26, 2021 due to the Covid-19 emergency.

With this in mind and owning CE certificates valid until 2024, HMC has planned the MDR (Medical Device Regulation) certification activities and has reorganized and strengthened the QA&RA Area aiming to be able to achieve the goal within the established time frame. The technical documentation of the first families of class I devices has already been completed and, by the end of the current year, HMC is preparing to release on the market the first medical devices compliant with the MDR Regulation.

Specific, targeted and specialized human resources are therefore dedicated to primary activities both in the Quality (QA) and Regulatory (RA) areas. Therefore, HMC intends to reply with ever greater effectiveness and efficiency to all requests and needs directly expressed by the medical devices market.