We are looking for us-based consultant who can help us conduct a review of our current 510k, evaluate the need for a supplemental 510k given the incremental changes since 2016 release. -develop plan and outline of work required for supplemental 510k -gather required documentation and submit to fda -remediate questions until completion. To qualify, please provide your feedback on the following: 1. Describe your experience with 510k submissions. 2. Describe key parts of a 510k submission 3. What challenges have 510ks presented you in the past? How did you overcome them? 4. What device class (i,ii,iii) does your experience include?
Rob |President / Consultant
Our firm routinely reviews device ***** the need to resubmit a 510(k). Our letter to fil...40 Minutes Later
Marie |Regulatory compliance/Quality System/ASQ
Hello: I can definitely assist with your 510K review and complete any required amendments in an eff...46 Minutes Later
Hi, I’ll be glad to assist you in: -Reviewing current product compliance status -Create a plan for ...49 Minutes Later