Our Services

Where Time to Market . . . Is Priceless 

We are highly qualified to assist you during all phases of product development, from proof of concept through the approval process. Some of our medical device consulting capabilities include: 

  • Regulatory strategy development
  • Presubmissions
  • Pre-IDE meetings
  • Protocol development, planning and review
  • FDA Registration and Listings
  • FDA Submissions [IDE, PMA, 510(k)]
  • FDA meeting managment and presentations
  • Quality Management Systems (QMS) and compliance
  • Regulatory agency liaison
  • FDA inspection preparation, onsite support, inspection recovery
  • Training corporate boards of directors on regulatory governance responsibilities 

As the process progresses, we will periodically review and adjust your regulatory strategy and plan to optimize the pathway to approval/clearance for your medical device, diagnostic, or combination product. The results to you are improved efficiency and lower costs, providing you with real value added at every level, especially the bottom line.