Hi,
My client is planning to go for a 510(K) approval of a product which is manufactured by an other company 'A'(who owns the complete technology) and is not ready to share the design drawings or Bill of Material to my client.
As I understand, my client who is going to be the potential owner of the 510(k) must maintain the complete DHF in his quality management system. Company A must register with FDA as a contract manufacturer. What are the options available so that it could be a win win situation for both (My client and the company).
I assume, the private label will not work here as my client is not purchasing a already approved product. My client will own the 510(k) and distributorship of the product.
Appreciate your thoughts.
Thanks,
My client is planning to go for a 510(K) approval of a product which is manufactured by an other company 'A'(who owns the complete technology) and is not ready to share the design drawings or Bill of Material to my client.
As I understand, my client who is going to be the potential owner of the 510(k) must maintain the complete DHF in his quality management system. Company A must register with FDA as a contract manufacturer. What are the options available so that it could be a win win situation for both (My client and the company).
I assume, the private label will not work here as my client is not purchasing a already approved product. My client will own the 510(k) and distributorship of the product.
Appreciate your thoughts.
Thanks,