Quality System with 510(k).

At evo820, we are a specialized Regulatory Affairs and Quality Assurance consulting firm that focuses only on medical device manufacturers who must comply with Title 21 CFR 820 of the FDA Current Good Manufacturing Practice Standards by operating under a Quality System (QS).

It is our pleasure to be your partner on a pathway to FDA compliance. evo820’s staff is here to provide you with our 53 years of Quality Assurance experience to make this process the least burdensome as possible. We speak your language, understand your business and work to customize a Quality System (QS) that is built specifically to your manufacturing and internal procedures.

We at evo820 are pleased to be your Quality Assurance partner and look forward to working with you in the years ahead to keep your company FDA compliant.


Call us at.