A medical device company files a marketing application with FDA and awaits a determination on whether or not its clinical trial data is sufficient to support product approval and/or clearance.
Topics: Quality Improvement, Medical Device Trials, FDA
You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
A medical device company files a marketing application with FDA and awaits a determination on whether or not its clinical trial data is sufficient to support product approval and/or clearance.
Topics: Quality Improvement, Medical Device Trials, FDA
A medical device company files a marketing application with FDA and awaits a determination on whether or not its clinical trial data is sufficient to support product approval and/or clearance.
Modern companies cannot operate today without a quality system and if they are sponsoring clinical research, oversight of clinical studies should fall under their quality system. CDRH conducts on the order of 300 Bioresearch Monitoring (BIMO) inspections per year and annually publishes details of its inspectional findings in medical device trials.
Topics: Quality Improvement, Medical Device Trials, BIMO