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.
Services We Provide.
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
QMS Audits
Complinance with Title 21 Code of Federal Regulations for Good Manufacturine Practices
FDA
- 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.