Achieving Success in your medical device 510(k) Clearance.
It is required that you have a clearance to sell and market your device in the US. This is not a device FDA Approval but demonstrating that your device is substantially equivalent to another device.
If you are a medical device manufacture and want to have access to the US market, evo820 will collaborate with you to obtain the 510(k) Clearance required to enter and sell your products in the US.
We are a full-service consulting firm to successfully collaborate with your manufacturing company to bring you, not only Regulatory Affairs complaint, but also FDA Quality Assurance compliant. We customize your documentation to suit your company needs and train your team on the management of the record keeping.