N
NicoleinFlorida
Hello cove,
We are a start-up medical device company located in the U.S. We are considering to introduce a new product as OBL. The OEM of this product has obtained CE mark. I am wondering whether this is feasible and how long it may take us to obtain the CE. This is a Class IIa product.
Comparing with the OBL marking, will it be easier for us to obtain 510k approval? We have two products that have been approved by the FDA.
Thank you for all your valuable inputs.
We are a start-up medical device company located in the U.S. We are considering to introduce a new product as OBL. The OEM of this product has obtained CE mark. I am wondering whether this is feasible and how long it may take us to obtain the CE. This is a Class IIa product.
Comparing with the OBL marking, will it be easier for us to obtain 510k approval? We have two products that have been approved by the FDA.
Thank you for all your valuable inputs.