Discover American Preclinical Services (APS)
Whether your company is a startup or an established industry leader, APS can offer a full range of medical device and pharmaceutical testing from our AAALAC and ISO17025-accredited, USDA-registered, and GLP-compliant facility located in Minneapolis, MN.
By utilizing our catalogue of services, you will be able to develop and conduct a full Preclinical Research Program and chart a path for your product from proof of concept to regulatory submission, all while using the industry’s most advanced capabilities. Trust APS with any size or type of project, and experience the place Where Medical Innovations Take Flight.
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To achieve truly revolutionary breakthroughs in the field of medical science, you need the right tools. At American Preclinical Services, we believe that philosophy extends not only to our state-of-the-art testing equipment, but also to our facilities as …
On October 25, 2017, the FDA released two final guidance documents: Deciding When to Submit a 510(k) for a Change to an Existing Device, which applies to medical device changes broadly, and Deciding When to Submit a 510(k) for a Software…