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 industryâs 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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On October 25, 2017, the FDA released two final guidance documents: âDeciding When to Submit a 510(k) for a Change to an Existing Device,â which applies to medical device changes broadly, and âDeciding When to Submit a 510(k) for a Software Change to an Eâ¦
FDAâs plan to engage the public in the agencyâs new effort to strengthen and modernize FDAâs regulatory framework
On 07 September, 2017, FDA announced its plan to engage the public in the agencyâs new effort to strengthen and modernize FDAâs regulatory framework. FDAâs goal is to ensure that its policies and regulations keep pace with the challenges encountered in prâ¦