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.
Depending on the specific case, we work in combination with the manufacturer. Hourly rate at €115.
Intellectual Property & Legal
Are you in doubt if this is the right service for you, or do you want to get more information about the service? Get in touch with the EIC Partner providing this service through this query form!
Is this the service you are looking for? If so, you can apply to the service through EIC ACCESS+! Eligible applicants can also get co-funding through the EIC ACCESS+ initiative. Find out more on the project webiste.
Receive up to €60,000 in grants, covering up to 50% of the costs, to access specialised services from the EIC Service Catalogue. Learn more on the EIC ACCESS+ website.