Regulatory GuidanceThe Experience Needed for FDA Clearance
Amplify shares your commitment to quality and regulatory compliance. We will work alongside your team to produce exceptional results through the regulatory journey. We provide superior solutions by utilizing and maintaining strong partnerships at every step of the process. Meredith May, Director of Consulting at Empirical Technologies, advises on launching safe new medical devices to market.
Validation & Verification
Amplify will take your idea to market, from regulatory consults to FDA 510(k) submission. By using our Quality Management System, we can repeat the desired output of excellence and compliance. Our experience includes designing, developing, and manufacturing the first six FDA 510(k) cleared orthopedic implants on the Q10 Platform.