QMedCo Clinical Evaluation consultancy services
Our Pre market phase services are designed to help you meet the pre clinical requirements for medical devices. We provide comprehensive Clinical literature reviews, Clinical Evaluation Strategy that lead to a robust Clinical Evaluation plan that is tailored to meet the specific requirements of your project. With our expertise and experience, we can help you navigate the complexities of the pre clinical evaluation process.
Pre market phase services
Clinical Literature
Review
Clinical literature review is crucial for medical device manufacturers as it provides a comprehensive understanding of the existing scientific knowledge and evidence related to the device and its intended use. It helps identify any gaps in knowledge, supports the development of a robust clinical strategy, and aids in the design of clinical investigations.
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Clinical Evaluation
Strategy
A well-defined clinical evaluation strategy is essential in MDR compliance as it ensures the generation of robust clinical evidence to demonstrate the safety, performance, and clinical benefits of medical devices, thereby supporting their regulatory approval and post-market surveillance.
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Clinical Evaluation
Plan
Our CE Consultancy offers a comprehensive Clinical Evaluation Plan to help you build robust clinical evidence for your medical device. Our experts will make sure your plan is MDR compliant, ensuring your device meets all regulatory requirements. Let us advise you on how to create a plan that will get your device to the clinical phase as quick as possible.
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