The application of Design Controls to IVDs

[Julie O]

I'm having a little trouble wrapping my head around the application of design controls to IVDs. I think that's because most of my experience is with traditional medical devices, and I inherently balk at the idea of "designing" an IVD. Does anyone here have experience with the application of design controls to IVDs?

 

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!

 

[Bev D]

Julie- IVD = In Vitro Diagnostics?

can you expand upon what you find difficult?

 

[Statistical Steven]

I'm having a little trouble wrapping my head around the application of design controls to IVDs. I think that's because most of my experience is with traditional medical devices, and I inherently balk at the idea of "designing" an IVD. Does anyone here have experience with the application of design controls to IVDs?

Julie

An IVD is not a traditional medical device in that many of the requirements are regulatory in nature, and not typical user requirements. I am going to leave out any instrumentation from this discussion, as that would follow normal DC and risk analysis. Typical user requirement might be time to first result, false positive/negative rates, storage conditions (refrigerated vs. room temp) or sample prep (serum vs. plasma). Once you have the user requirements, the normal DC process is followed with V&V testing the culmination of the activity. Are there any specific questions you have?