We assist companies with complete planning of their test programs so that all FDA, EU Medical Device Directive, and other regulatory requirements will be addressed. Our active membership in standards organizations such as ASTM International gives us timely insight into the regulatory environment.

We also help venture capital firms and medical device companies perform technical file due diligence in evaluating their potential investments and acquisitions. We can provide the laboratory space for an in vitro clinical or engineering evaluation, review the technical file for the potential product, or review a company’s entire test program.