This could be a helping hand in getting the required information to the FDA for medical devices with the format and information they need and could save time in having all the information together at once and potentially avoid some letters sent by the FDA asking for additional information.  Processes are getting more complicated today and this appears to be a new area of expertise that is evolving.  BD  

Factory CRO is the latest addition to the AmeriStart portfolio of world-class Contract Research Organizations (CROs) and other service providers to the Life Science industry.

AmeriStart will apply and promote Factory's expertise to companies seeking both CE Marks and FDA approvals, including 510(k) designations. AmeriStart will promote Factory CRO's considerable clinical research capabilities in the growing North American medical device market.

Dutch Company Factory CRO Chooses US-based AmeriStart to Promote Its Medical Device Clinical Services to the American Market - MarketWatch

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