Regulatory

Regulatory

Digital Anatomics S.L., is approved for the manufacture of custom-made surgical guides .

Surgical guides designing and manufacturing processes are carried out under the quality management system which Digital Anatomics has implemented and certified according to ISO 13485. This ensures correct compliance with the requirements of Regulation (EU) MDR 2017/745, listed in its Annex I (General Safety and Performance Requirements) and Annex IX (Quality Management System).

Digital Anatomics issues a Declaration of Conformity for each medical device, stating that it has been designed and manufactured in compliance with the requirements of the current legislation on medical devices.

Under the frame of the European MDR 2017/745, but in addition to that, in the case of Spain, Digital Anatomics:
• Has obtained the corresponding Preliminary Operating Licence as Custom Made Medical Device Manufacturer nº FPS 00919/M (in accordance to RD 1591/2009 – article 10 and RD 437/2002)
• Is registered as Responsible for Custom Made Medical Devices at the Spanish Medical Agency (AEMPS) under registration number: RPS/135/2022.

ISO 13485 Certified

Digital Anatomics has the ISO 13485 quality certification, specific for Medical Devices, and accredited by ENAC (1), which ensures that:

  • our biomodels and surgical guides are designed with precision and avoid any risk to the patient
  • they are manufactured with safe biocompatible equipment and materials
  • each case is individually monitored before, during and after surgery, which shows that our commitment is focused on patient´s safety.

(1) ENAC: National Accreditation Entity.

ISO 14001 Certified

Digital Anatomics has the environmental certification ISO 14001, accredited by ENAC (1) and that endorses our honest commitment with the Sustainability. Our day to day is developed around the good environmental practices, being its main axis the 3Rs of Sustainability: Reduce, Reuse and Recycle. To this end, we rely on new technologies aligned with this culture. The integration of new water-based resins into our processes and products is one of the most important projects we are working on.

(1) ENAC. National Accreditation Entity