THE PROJECT
Facilitating Ethical and Notified Body Approval
The aim of Med Fast Track 2 is to analyze the preliminary phases of a medical device and address any regulatory gaps that could compromise ethical and notified body approvals.
The main objective is to conduct an analysis of the manufacturer’s characteristics, quality systems, and UNI EN ISO 14155:2020: a technical standard providing organizational, managerial, and regulatory tools for the proper execution of clinical studies involving patients, enabling the application of evidence-based medicine methods in the field of medical devices.
THE FOCUS OF A CLINICAL INVESTIGATION
Assessment of effectiveness
Assessment of safety
Assessment of compliance
Improvement of existing devices
OTHER SERVICES
Clinical Investigations
The clinical investigations section aims to provide support for scientific studies and trials conducted on medical devices to evaluate their effectiveness, safety, and compliance with regulatory standards before they are marketed and used on patients.
Med Fast Track
The Med Fast Track section provides support and assistance to companies in the medical sector (medical devices and in vitro diagnostics), including start-ups and innovative SMEs, in obtaining CE marking. This includes concrete support starting from the assessment of the maturity of the project idea.
Training
Multidisciplinary 360° training on the processes of creation, certification, and development of health technologies.
CONTACT US
Contact us by email. Your request will be handled by our team, and you will be contacted as soon as possible.