We
Provide.
evo820 provides a variety of FDA Regulatory Compliance consulting services and resources to help every company and organization effectively and efficiently reach their goals. evo820 is Quality and Compliance defined.
We provide the expertise to obtain the US FDA 510(k) Clearance for companies wanting to distribute medical devices in the United States.
We support our clients with development of a Quality Management System (QMS) that is compliant with the FDA’s Title 21 CFR 820 that guides companies on the FDA current Good Manufacturing Practices and provides the training on how to install a QMS and manage the documentation.
evo820 Audits your QMS to assure that you are prepared for the FDA Inspection and have all your documents in order.
When the FDA announces that an FDA inspector is coming, we work with our clients to prepare for the FDA Audit.
The FDA’s Audit resulting in 483s or Warning letters, evo820 will assist with the appropriate response to the FDA and satisfy their required corrections from the FDA Audit.
evo820 stands with their clients to assure success in maneuvering the FDA requirements.
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 DentalI 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 CentresServices.
510(k) Submissions
Medical Devices
FDA Registration
Importers, Distributors & Manufactures
United States Agent
Represent your company with the FDA
Quality Management Services
Quality Assurance
Quality System Training
Proper Document Control and Recording
