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.
Đăng ký FDA
Nhà nhập khẩu, Nhà phân phối & Sản xuất
Đại lý Hoa Kỳ
Đại diện cho công ty của bạn với FDA
510 (k) Bài nộp
Các thiết bị y tế
Dịch vụ quản lý chất lượng
Đảm bảo chất lượng
Đào tạo Hệ thống Chất lượng
Bảo Đảm kiểm soát và ghi lại tài liệu
Đảm bảo Kiểm toán
Tuân thủ với 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.
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 Centres