M
Martin_v_W
Dear all,
we are a titanium dioxide pigment manufacturer and currently develop a new pigment for plastics. We already have FDA food contact clearance and I wonder what is needed to open medical device markets in USP class I and II.
Most threads for medical device certification only talk about the manufacturer, not their plastic compound supplier and, even further up the chain, raw material manufacturers like us.
What kind of information do we need to supply to the value chain and what is our liability in providing a raw material into this application? What can we do to help the device manufacturer get his 510k for class II applications?
Thanks & best wishes,
Martin
we are a titanium dioxide pigment manufacturer and currently develop a new pigment for plastics. We already have FDA food contact clearance and I wonder what is needed to open medical device markets in USP class I and II.
Most threads for medical device certification only talk about the manufacturer, not their plastic compound supplier and, even further up the chain, raw material manufacturers like us.
What kind of information do we need to supply to the value chain and what is our liability in providing a raw material into this application? What can we do to help the device manufacturer get his 510k for class II applications?
Thanks & best wishes,
Martin