Hello,
I was hoping to get some information regarding the requirements for testing of class 1 device (hardware and software). We have the license to sell the device. Currently we are debating the level or extent of device verification and validation that is required before we sell. For verification we can do inhouse performance testing and for 60601-1, SPE-3000 inspection by CSA (this is not as detailed as 60601-1) but does confirm the device safety. What level of validation would be needed?
Thanks
Nav
I was hoping to get some information regarding the requirements for testing of class 1 device (hardware and software). We have the license to sell the device. Currently we are debating the level or extent of device verification and validation that is required before we sell. For verification we can do inhouse performance testing and for 60601-1, SPE-3000 inspection by CSA (this is not as detailed as 60601-1) but does confirm the device safety. What level of validation would be needed?
Thanks
Nav
Last edited:
