Formulation testing/ material testing


We have a medical device that we developed and we plan on getting approval in Europe (CE mark) and states (FDA) but we cannot measure one of the constituents of the formulation. I.e we cannot quantify/qualify that one of the materials we add during production is present and we can’t quantify it.

Is it required that we must be able to measure Quantitatively and/or qualitatively detect it(i.e. is it present?)?


Is it sufficient to risk assess it? And what risk assessment would be suitable to ensure safety to user

Ps the percentage in finished device is < than 1%


I think, material you are used is chemical and is used in the manufacturing of the above device or coating a device or something else.

If your laboratory is not capable of doing it, please go with IICT- Indian institute of Chemical technology [hyderabad, andhra pradesh, INDIA] or any other National level laboratory in your country, to identify and quantify it.

It may solve you problem.