Hi, We have been made aware of the Bill 96 and Quebec's language law, we sell class 1 medical devices in North America and we are just wondering if anyone can give me some advice on what documents need to be in French? Many thanks Lucy ------------------------------ ...

Dear the RAPS community, Our company has developed an IVD product that uses RT-qPCR method for cancer diagnosis. This product has been validated on a number of PCR platforms, each platfoms has its own cut-off value. However, due to updates of PCR platforms ...

This message was posted by a user wishing to remain anonymous In preparation to submit 510k application, does anyone have recent experience on how long it actually takes the FDA to make their determination once they receive form FDA 3602? Current FDA ...

This message was posted by a user wishing to remain anonymous Hello dear colleagues, We are currently developing a process for transferring regulatory requirements from standards, regulations and guidelines into product-related requirements. ...

Dear Colleagues, I am seeking confirmation on the following queries regarding the forthcoming Windsor Framework regulation: Will the regulation require changing the testing and batch release activities currently performed in Ireland to Northern ...