Andrews-Cooper was founded by two engineers working for a large Medical Device firm.
That was in the year 2000. Since then the company has continuously helped small and large medical device firms design, develop and manufacture their products. We have experience with Class I, II, and III medical devices and offer an FDA and ISO compliant, gated, multi-phased development approach.
As to staff, many have more than two decades of experience in medical device.
Of note, not only do we understand the regulatory process, we have engaged with clients specifically to lend that expertise. In fact, one top 10 Pharmaceutical firm has engaged our team in due-diligence around the small device firms they acquire. This includes a review of the product and its likelihood to successfully complete the regulatory process.