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Medical Device Design Services

Bringing a new medical device to market is an exacting process. In addition to developing the basic technology, there is lots of regulatory work to be done. AB Tech Solution engineers have been successfully brought many medical instruments to market, and can help you bring yours to market at a lower cost than you might expect!

FDA, EMEA, cGMP, 21 CFR Part 11 Compliance

No job is complete until the paperwork is done. This is especially true for medical devices, which are regulated by the FDA and other agencies. Our engineers have been through the process, and we can assist you with your 10K and other documentation to get your product approved.