During the auditing and assessment process, we will examine the medical device software to verify that it meets the design and functional specifications, and that it is operating correctly. We will also evaluate the risk management documentation to ensure that all potential risks have been identified and mitigated.
Our team of experts will perform a gap analysis to identify any areas where the software may not meet regulatory standards, and we will provide recommendations for how to address any deficiencies found. The goal of the auditing and assessment process is to ensure that the medical device software is safe, effective, and compliant with regulatory requirements.
