In the process of acquiring medical device companies or licensing their technologies, many of our customers have had challenges determining the software’s compliance to FDA, European, and other worldwide standards.
CriTech will examine the software’s Design History File and/or Technical File of the potential acquisition and provide a report on the compliance and completeness of the device’s software. If needed, we can perform a more in-depth and rigorous investigation into the quality of the software and its related documentation, including detailed reviews of software verification.
We look forward to talking with you!
We are ready to assist in getting your medical device software compliant and can start at any point during your life cycle process!