Dianyx Innovations engaged RookQS to support our efforts in pursuing 510k approval for our flagship product- a technology-enhanced sleep appliance (t.e.s.a.)
After working with a previous FDA consultant, Rook’s experience, professionalism, and process-driven approach were refreshing to say the least.
RookQS quickly aided in preparing Dianyx for pre-submission – developing the correct documentation, and supporting our team in the compilation while interfacing with the FDA to schedule the meeting.
I would recommend RookQS to start-ups and established companies for support in their journey towards regulatory approval.
