(541) 604-9654

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 jepordy

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

We also have off the shelf quality systems, both paper and electronic