Barkilden inc.

We specialize in finding, developing and distributing new and innovative medical technologies that look to disrupt the status quo and improve patient outcome and user satisfaction. 

Each product has been carefully evaluated by our chief medical officer in order to release what we feel is the best solution in its respective market sector. We then conduct thorough market research and design a strategy for the successful release of the product utilizing all the tools at our disposal. If you have something you'd like to bring to market, we're here to help.

From clinical trial conceptualization to regulatory approvals, our team leader has over 20 years of experience in the field. 

Examples of what we can provide:

• Creating and presenting submissions for approval by FDA
  
• Regulatory compliance
  
• 510(k) process and 510(k) clearance
  
• EUA consulting (Emergency Use Authorization) - emergency use preparedness and response
  
• Regulatory strategies to assist medical devices for a direct to consumer path
  
• Development of research protocols to expedite approval
  
• Market research strategies to test product viability prior to regulatory pathways
  
• Project management
  
• Clinical study recruitment
  
• Site selection
  
• Interface with data management