Compliance In Focus

Merriam Webster defines a case study as a published report about a person, group, or situation that has been studied over time; also : a situation in real life that can be looked at or studied to learn about something.  Case studies can be useful to help highlight how to handle a particular situation, including the eventual outcome.

Recently, a clinical site received a call from an inspector on a Thursday notifying the site of a not-for-cause inspection the following Monday. This was a short gap of time between the notification and actual audit conduct. How can sites make sure they are ready if an inspector calls today?

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.

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.