M ao Cubo – Regulatory Consulting provides consulting support for the registration/notification of medical devices, an essential healthcare area since it covers a wide range of health products.
Our qualified professionals make easier to manufacturers and distributors representatives the fulfilment of the legal obligations in this area, namely licensing and documents preparation to notify and/or register of:
- Medical devices class I, IIa, IIb and III
- Active implantable medical devices
- in vitro diagnostic medical devices
We can also deal with the Medical Device Vigilance System, set in place to improve the protection of health and safety of patients and users, by reducing the likelihood of reoccurrence of incidents related to the use of a medical device.