- Preliminary assessment of the technical documentation necessary for the certification of medical devices (I, IIa, IIb and III class) in the EU.
- Preliminary assessment of the compliance of a Manufacturer Quality System with the ISO 13485 requirements.
- Full support in case of inspection carried out by any EU Notified Bodies or EU Regulatory Agencies.
- Full support in case of notification of incidents or FSCA to the Authorities responsible for Medical Device Vigilance, in Italy or abroad.
- Advisory services for the registration of medical devices on the Italian National Database.
- Request of Free Sale Certificates to the Competent Authorities.
- Advisory services for the advertising of medical devices in Italy.
