One of our specializations: consulting on medical device regulations.

Our specialization in European regulations related to the production and commercialization of medical devices is the result of extensive experience in this sector, which began in 1995.

Today, we are experts in the field and, through our comprehensive consulting service, we are able to guide companies operating in this sector with a complete vision. We help them correctly manage the application of regulations, compliance with certifications, and the conformity of technical documentation related to their product.

With the recent introduction of the New European Regulation on Medical Devices (Regulation 745/2020, effective May 26, 2021), companies manufacturing medical devices face numerous regulatory and procedural changes that impact product management processes and technical documentation.
These are mandatory procedures that must be followed to obtain the necessary certifications for producing and marketing the product.

Our consulting service offers the advantage of a comprehensive approach to the application of this new regulation, managing all aspects involved in compliance with the relevant European framework. In summary, our support covers:

• Application of the regulation for Class III medical devices according to EU Regulation 745/2020 for product certification and market introduction;

• Verification of compliance in submitting the certification request and technical dossier according to CER regulations;

• Verification of compliance in submitting the certification request and technical dossier according to PMS regulations.

We oversee every aspect, working closely with the company and guiding it throughout the entire process. We coordinate internal company functions and external professionals required to obtain all necessary certifications and procedures to ensure a fully compliant product.

In practice, our consulting approach places us in the role defined by the regulation itself as the Responsible Person for the product, ensuring oversight and control of the device’s manufacturing as well as post-market surveillance activities.