Clinical Investigation Services
Clinical data is an important element of the device manufacturer's technical file, and a requirement for global regulatory approvals. The data may come in the form of a clinical evaluation, or a thorough review of all studies and data currently available on the device and its use. When the existing data is not sufficient for regulatory approval, the device manufacturer can use a clinical investigation to demonstrate the device is safe and effective, the instructions for use are clear, and that any risks have been effectively mitigated.
MDT, part of the UL family of companies, is a Clinical Research Organization (CRO) and provides support throughout the entire clinical investigation, including project management, medical writing, monitoring and quality assurance, data management & statistics and training. We effectively carry out clinical investigations under the harmonized standards EN ISO 14155 for active and non-active medical devices (MDD) and active implantable medical devices (AIMD). In principal, our customers can choose between "full service" or individual services as needed.
For more information on our full service approach to clinical investigations, click here.
- Online course "European Strategies for the Evaluation of Clinical Safety and Effectiveness of Medical Devices" Click the link for a full course description.
Article: Clinical Evaluation of Medical Devices Pursuant to MEDDEV 2.7.1: Cumbersome Burden or Cost-Effective Opportunity? (Registration required)