If you have…

  • developed a new medical device, and now you want to get it cleared by FDA
  • just been called by FDA or your notified body and they will be inspecting or auditing your facility
  • just received a FDA-483 that you need to respond to in 15 days
  • a quality system that is managing you
  • compliance with ISO 13485, but you need to upgrade to 13485: 2016,
  • a large backlog of unresolved CAPAs or complaints that are putting your business in regulatory jeopardy

We can help you with over 20 years experience…

  • writing 510(k)s for complex electro-mechanical and Software as a Medical Device products
  • preparing facilities and training employees to optimize FDA and ISO inspection and audit outcomes
  • responding to FDA and ISO inspection observations by creating remedial action plans and preparing responses that anticipate potential objections by the agencies
  • writing, implementing, managing and defending ISO, FDA, CMDCAS quality systems
  • resolving backlogs of CAPAs, complaints and non-conforming material reports

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