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Clinical Study Processes:
It is as stated in MEDDEV 2.7/1 rev.4;
Clinical evaluation; It is within the scope of the evaluation and verification of the clinical safety and performance of a medical device during application depending on the time it is used in accordance with the appropriateness of its use. The main steps of the clinical evaluation consist of planning, evaluation and analysis of clinical data.
The Clinical Evaluation Plan is an asphalt texture where clinical evaluation studies are created in advance and expanded for licensing standards and management opportunities.
Post-Market Surveillance (PMS)
Post-Market Surveillance (PMS) activities are provided to a customer where the performance and safety of medical devices are monitored sustainably after their launch.
It operates within the PMS; It aims to collect information about the usage problems related to devices, design characteristics and clinical data obtained in clinical studies instead of the supply office. It undertakes that the necessity of the protection activities after the launch of a medical device will be carried out immediately after the launch of the medical device.
