Director of Operations – Class II and III device Manufacturer

“…Regarding the 510k submission that you conducted for [us], we were very satisfied with the results…You worked in concert with our QA department to keep the process on task and meet our project deadlines. I was impressed by your work with the FDA personnel when the document was submitted. You were able to get it submitted and reviewed promptly. When FDA had a request for additional documentation, you were able to provide a template for our Patient Instruction booklet that allowed us to complete the content efficiently…”