We have noticed that our current clinical evaluation report does not meet the MDR requirements due to unsatisfactory documentation. Eventhough all clinical tests and results are good enough for proofing the product usage the consultant company did not properly documented as regulatory requested format and contents .So we need to reorganize CER report and need a new company/individual to assist us. Our intention is to work with a competent and reliable agent. In addition to CER work we also need to rework on some tests(Biocompatibility).
So I need your guidance and recommendation for selecting a test center and CER process.Do you know any source for recommending us?
This website stores cookies on your computer. These cookies are used to collect information about how you interact with our website and allow us to remember you. We use this information in order to improve and customize your browsing experience and for analytics and metrics about our visitors both on this website and other media. To find out more about the cookies we use, see our Privacy Policy.
If you decline, your information won't be tracked when you visit this website. A single cookie will be used in your browser to remember your preference not to be tracked.