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Clinical evaluation
Clinical evaluation is a cornerstone of regulatory approval. Let our experts support you in planning and conducting a thorough clinical evaluation that supports your medical device.
Clinical evaluation of medical devices
Clinical evaluation is a mandatory requirement of EU MDR 2017/745 for all medical devices, irrespective of risk class. The clinical evaluation aims to ascertain that there is sufficient clinical evidence in support of product safety and performance. Clinical evidence for a medical device is generally based on clinical data, which means results from the clinical use of the device or an equivalent device. If there is no previous clinical data, a clinical investigation may be required.
The clinical evaluation is based on the clinical evaluation plan which is set up to reflect the intended purpose and risk profile of the device. After a thorough and objective analysis of the available clinical data, conclusions on whether the requirements of EU MDR 2017/745 are met are documented in the clinical evaluation report. As part of the clinical evaluation, a literature review is performed. The clinical evaluation must be followed up and reassessed throughout the entire lifetime of the product.
Our team of experts can support you with:
- Establishing a clinical strategy
- Setting up a clinical evaluation plan
- Performing a literature review
- Performing a critical analysis of clinical data
- Writing a clinical evaluation report
- Custom or open training sessions for your team
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