In our series on the life path of medical devices, today we’re discussing the critical phase of conducting clinical trials. This step is essential to ensure that medical devices meet the strictest regulatory requirements and are safe and effective for patient use.
What are the key tasks involved in clinical trials?
✍️ Compiling the Clinical Investigation Plan (CIP) based on MDR and ISO 14155
✍️ Developing the Investigator’s Brochure (IB) as per MDR and ISO 14155
✍️ Compiling essential documentation for the study
✍️ Conducting feasibility studies in participating countries
✍️ Obtaining regulatory approvals from the Competent Authority and Ethics Committee
✍️ Conducting the clinical trials
✍️ Collecting & evaluating data
With ample expertise, BiTrial offers comprehensive end-to-end service support, ensuring seamless integration and execution across all stages of the clinical trial conduction.✔️
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