CLINICAL EVALUATION REPORT
We specialise in clinical evaluation report writing. Our team can help you prepare reports that meet the regulatory requirements required to conduct Clinical Evaluation, such as the EU Medical Device Regulation (MDR) and the relevant guidance from the Medical Device Coordination Group (MDCG).
The MDR and MDCG have specific requirements for clinical evaluation reports:
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The need for a comprehensive clinical evaluation plan.
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An assessment of the clinical data.
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A conclusion regarding the safety and performance of the device.
Our team of experts can assist you with all aspects of clinical evaluation report writing, ensuring that your reports meet these requirements and are of the highest quality. We assist with gap analyses of existing Clinical Evaluation Reports, suggesting areas to strengthen based on regulatory requirements and current guidance documents. We also help you design and develop clinical evaluation templates and procedures that meet the highest regulatory standards.
What we offer
Clinical Evaluation Plan Development
We work with you to develop a comprehensive clinical evaluation plan that outlines the scope, objectives, methodology, and data sources for your clinical evaluation. We ensure that your plan meets the requirements of the MDR and the relevant MDCG guidance and is tailored to the specific needs of your device.
Clinical Evaluation Report Writing
We prepare comprehensive clinical evaluation reports that meet the requirements of the MDR and the relevant MDCG guidance. Our reports include all necessary information, including the clinical evaluation plan, assessment of clinical data, and conclusions regarding the safety and performance of your device.
Clinical Data Assessment
We conduct a thorough assessment of the clinical data for your device, including clinical studies, post-market surveillance data, and other relevant information. We evaluate the quality and relevance of the data and ensure that it supports the safety and performance of your device.
Regulatory Submission Support
We provide ongoing support throughout the regulatory submission process, ensuring that your clinical evaluation reports are complete, accurate, and meet all regulatory requirements.
Committed to providing high-quality, reliable services.
Our team of experts have a thorough comprehension of the regulatory requirements for clinical evaluation report writing, including the MDCG guidance, and we are committed to providing high-quality, reliable services that meet the needs of our clients. Contact us today to learn more about how we can help you prepare clinical evaluation reports that meet the regulatory requirements of the MDR and the relevant MDCG guidance.