Daniel & Daniel Consulting has been helping small to medium size medical device companies develop clinical and regulatory strategy, complete clinical studies
and gain FDA product clearance/approval
since 1985.

Over the past 29 years (1988 thru 2017), Daniel & Daniel Consulting, LLC has obtained clearance / approval for 100+ FDA submissions [e.g., IDE, Q-Sub, 513(g), 510(k) and PMA] for 20+ different device categories including IVDs, OBGYN, General Surgery, Cardiac Surgery, Cardiology, Gastroenterology, Neurology, and Vascular devices. Products have included: implantable, diagnostic, endoscopic, trans-oral, percutaneous, surgical, trans-cutaneous, software, disposable, and electro-mechanical robotic 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
4) Robotics and computer controlled / guided devices
5) RF ablation
6) Implantable circulatory support systems
7) In vitro diagnostics (IVDs)