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 read more
Hi Anon, VCLS and their Digital health group can assist you with regulatory development for a software MD in the US Kind regards, Clara ------------------------------ Clara Desvignes Associate read more
Please feel free to contact me at ranjit@kitemedicaltech.com. I will ensure your needs are met within your budget. I am a former BSI auditor and exactly know what auditors are looking for. Regards, read more
This message was posted by a user wishing to remain anonymous I agree with everything Richard posted, but I wanted to add some addition information. IDEs are approved/disapproved on the basis of safety read more
This message was posted by a user wishing to remain anonymous May be superseded by the IMDRF documents - see App A? https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech- read more
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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 ...
This is a great opportunity for those looking for positions within FDA and even those just wanting to spruce up their resume! DC/Baltimore Area Chapter Virtual Event: Tools and Tips To Enhance Your FDA Career Application| RAPS ------------------------------ ...
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