Who Is evo820?

evo820 Collaborates on Pathways to Regulatory Success

With the years of business experience that we bring to your project, evo820 provides trusted guidance for your Regulatory Affairs or Quality Assurance project that leads us to a successful conclusion.

We understand the FDA requirements and provide clear guidance, training and document management that keeps you in regulatory agency compliance.

evo820 is led by respected and highly knowledgeable industry professionals, evo820 takes the headache and confusion out of the FDA’s Title 21 CFR 820 guidance and 510(k) Submissions.

Dịch vụ.


  • Satisfy the FDA with a customized, practical and affordable quality management system for medical device manufacturers.
  • We help medical device manufacturers evolve into entities that are Title 21 CFR 820 compliant.

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Client Testimonials

Through working with evo820 I have been able to bring our companies into compliance with the FDA; a process that would have been very daunting alone. They brought a wealth of experience and expertise that extinguished all unease we had about becoming compliant

Travis Gasser, Owner - PDA Dental Laboratory, CTO - Cadmus Dental

I hired evo820, because I don’t know regulatory like they do. Tim and his team did a great job analyzing what we do and created a truly customized Quality Management System to satisfy the FDA requirements. Now I don’t have to think about it, they have my back

Greg Harris , General Manager - USA Core3d Centres