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