Medical Device Industry Solutions
The FDA Center for Devices and Radiological Health (CDRH) is responsible for those firms that participate in manufacturing, repackaging, relabeling, and or importing of medical devices sold within the United States. Various medical devices are categorized from Class I to Class III, and regulated with stricter guidelines as class increases.
The path to FDA approval of your new medical device is rigorous. Any invasive medical tool, or one that provides critical patient data is going to require a great level of trial and evaluation prior to entrance into the health care setting.
At Clindata Insight, we are equipped with the expertise to advise and support your effort towards approval.