Over the past 25 years Daniel & Daniel Consulting has successfully designed and completed over two dozen clinical studies (12+ IDEs), and obtained FDA clearance or approval for over 50 medical devices.

Our expertise includes:
1) Clinical study strategy, design and negotiation with FDA
2) IDE submissions, negotiations, and approvals
3) Clinical study management to successful completion
4) 510(k) or PMA strategy, submissions, negotiations and
    clearance / approval
5) Post-market and investigator initiated studies
6) Regulatory compliance and quality systems
7) FDA and Notified Body inspections and audits

We have worked repeatedly in the following technology areas:
1) Endoluminal and transoral devices
2) Percutaneous, peripheral and coronary catheters
3) Clips, staplers, fasteners, and other anastomomotic / closure
    devices
4) Robotics and computer controlled / guided devices
5) RF ablation
6) Implantable circulatory support systems
7) In vitro diagnostics (IVDs)