Clinical Trials

Your partner for Pre- and Post-market Clinical Investigations

The new Medical Devices Regulation (EU) 2017/745 (MDR) has been in effect since the 26^th of May 2021 in order to create a robust, transparent, and sustainable regulatory framework, recognised internationally, that improves clinical safety and creates fair market access for manufacturers and healthcare professionals.

This new framework sets high quality and safety standards for medical devices:

• Increases requirements for clinical evidence and user safety.
• Raises standards for technical data which is mandatory for marketing and clinical investigation application of class I to II medical devices.
• Ensures the reliability and robustness of data in clinical investigations.
• Ensures the safety of subjects participating in clinical investigations.

With more than 30 years experience in testing medical devices, we have eight research centres acting as CRO and CRC to assist with the different steps of setting up of your clinical investigations: 

• Employees trained on the Medical Devices Regulation and guidelines.
• Several applications according to the new regulation successfully completed (mono- and multi-centric; mono- and multi-national).
• Database of qualified investigators and sites for use of medical devices established (including key opinion leaders for different indications).
• Access to a global database of healthy subjects or patients (different ethnic groups, various inclusion criteria / pathologies / medical practice habits).
• Full-CRO with in-house medical experts dedicated to medical device use.
• Two services acting as CRO and CRC: expertise in conformity with ISO 14155 and GDPR standards as requested by MDR
• Process for SAE management and reporting in place.
• Full-service capacity for investigations according to the regulation (including project management, specialised regulatory submission management, data capture and management, statistical planning and analysis and medical writing).
• In-house clinical trial facility with expertise in medical device investigations.

Services are performed according to Chapter VI and Annex XV of the Regulation in order to complete your Clinical evaluation report or Post-market Clinical Follow-up. As an accredited and state-of-the-art laboratory, we guarantee total compliance with new regulation requirements and with ISO standard 14155:2020 (Clinical Investigation of Medical Devices for human subjects – Good Clinical Practice), ethical principles and General Data Protection Regulation standards.

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