Clinical Evaluation

Compliance with MDR requires a robust Clinical Evaluation to demonstrate the safety, performance, and clinical benefits of a medical device. This process involves a systematic assessment of clinical data related to the device. In the context of Clinical Evaluation, IPN services include:

• Development of a Clinical Evaluation Plan (CEP): Defining the scope, methodology, and objectives of the evaluation, tailored to the device and its intended use.

• Identification and Appraisal of Clinical Data: Systematic collection, appraisal, and analysis of clinical data from existing literature, clinical investigations, and post-market sources.

• Elaboration of the Clinical Evaluation Report (CER): Compilation of all findings into a detailed CER aligned with MDR requirements to support regulatory submissions.

• Gap Analysis: Evaluation of existing clinical data to identify gaps and strategies to address deficiencies, ensuring compliance with regulatory standards.

This service ensures a systematic and compliant approach to clinical evaluation, supporting regulatory approval and lifecycle management of medical devices.