Clinical evaluation and trial support

At be-on-quality, we support you throughout the entire process of clinical evaluation and clinical trials for medical devices. We develop compliant Clinical Evaluation Plans (CEP) and Reports (CER) in line with EU MDR and MEDDEV 2.7/1 Rev. 4, ensuring your clinical evidence meets regulatory expectations. Our services include literature reviews, equivalence assessments, and post-market clinical follow-up (PMCF) strategies. For clinical trials, we assist with protocol design, ethics submissions, site coordination, and data analysis. Whether you're launching a new device or updating existing documentation, we help you generate robust clinical evidence to demonstrate safety, performance, and regulatory compliance. Development of compliant Clinical Evaluation Plans (CEP) and Reports (CER) in line with EU MDR. Our services include literature reviews, equivalence assessments, and post-market clinical follow-up (PMCF) strategies. For clinical trials, we assist with protocol design, ethics submissions, site coordination, and data analysis. Outcomes can be Clinical strategies, data analysis plans, Clinical evaluation plans and reports.