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FDA experts who have been the regulator and worked in the regulated industry. Like no other FDA consultant you will find.  An expert witness like no other on the FDA regulation of medical devices.

 

Our Mission

Our mission is to eliminate any FDA issues that might face your company.  We want to help get your device to the market sooner, to assure your quality systems meet FDA requirements, and when FDA issues occur solve them in a timely and successful manner.  We guarantee success. 


“As a small and innovative organization with a Class III medical device in the PMA process we had the need to prepare for FDA PAI audits of both our headquarters and our contract manufacturer. We reached out to One Way Consultants as a resource to perform the necessary audits. I am very pleased with the results. The resource had extensive prior FDA and industry experience and was easy to work with. He performed thorough and professional audits and provided a list of actionable recommendations. As a result we now have an increased level of readiness for the upcoming FDA PAI audits. I highly recommend use of One Way Consultants, as a source of FDA expertise.”
— CEO, Class III device manufacturer

What We've Achieved

  • Create a FDA Strategic Plans for a start up companies.
  • Serve as a Regulatory/Quality mentor for junior employees in a start up.
  • Met with clients at FDA to solve regulatory issues.
  • Perform MOCK FDA audits to assess Quality Systems for FDA compliance.
  • Serve as an Expert Witness
  • Prepare responses to FDA-483 observations and FDA Warning Letters
  • Review design control operations to assure all FDA required elements are present.
  • Evaluate CAPA programs to assure effectiveness and FDA compliance.
  • Regularly perform Webinars on FDA issues.