In Field Validation Requirements

S

scotthowells

Registered
#1
#1
Hello,
I am looking for some advice in relation to In-Field Validation (IFV) requirements of a Reusable Medical Device (RMD). Our medical device is similar to a washer disinfector and we claim partial compliance to ISO15883. There are no services provided to the device (water, air) only requirement for use is power. Device is marketed (and approved) in EU, US and Australia/NZ.

In ISO15883 there are requirements relating to IFV and locally in Australia we also have AS/NZS 4187 applicable to HSO, that points back to 15883. My question is:

With a device, where the design is verified and validated, do you still need to conduct IFV?

Some HSOs have IFV as a requirement of the service provider (we also provide preventative maintenance annually). We offer IFV, however can a justification be indicating IFV is not required for the product on the basis of the design? I should add there is an independent confirmation used as part of the disinfection cycle.

Thanks,
Scott
 
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L

levatorsuperioris

Involved In Discussions
#2
#2
yes its installation in 13485...

It depends what annex your certification for EU/AUS was accomplished, Annex 2 is tech file and QMS... Thus you are subject to basic installation requirements. Annex 3 is type testing....
 
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