FDA BIMO Audits Preparation

FDA BIMO Audits Preparation

The FDA Division of Bioresearch Monitoring (BIMO) regularly performs pre-submission audits of PMA and 510(k) clinical data and IDE submissions, as well as various facility inspections.

To assist clients in preparation for these types of audits and inspections, our team will conduct announced or unannounced mock inspections, based on FDA medical device regulations, to assess clinical trial conduct under your quality system, SOPs, staffing levels, organizational structure, and specific study files, followed by customized training and education.

We will also conduct pre-FDA site visits to ensure your clinical study sites are FDA inspection ready.

Contact us to learn more about how Aptiv Solutions can help you to prepare for an FDA BIMO Audit.