Our Services

To achieve and maintain compliance with Regulation (EU) 2017/746.

Full-service planning and management of clinical investigations or post-marketing data collection.

Secure and effective integration of AI in medical devices.

Verification and assessment of compliance of Software as Medical Device.

Analysis of available data or generation of new data through the definition of an evaluation plan and the drafting of a report.

Analysis of available data for the biological evaluation of a medical device.

Correct implementation and maintenance of a Quality Management System.

Internal audits, supplier qualification, distributors, importers, and representatives to ensure compliance with industry standards.

Tailored training for individuals and companies on quality management, regulations, supplier qualification, and risk management.