Hello,
My company wants to purchase a motor for surgery. It is CE marked in class IIa for a different indication for use than the one we want.
We want to connect our own instruments to this motor and use it for our own indication of use. It is class IIb. We want to mark it CE for pre clinical tests. The main standard to undertake is 60601-1.
We've never had this case before. What we plan to do is:
-redo the risk analysis with our own IFU and instrument,
-produce the risk management proofs with the following cases
1.a sub set of risks are mitigated by the proofs given by the manufacturer of the motor
2.the other risks shall be mitigated with our own proofs
Any comments on this plan ?
Thanks a lot.
My company wants to purchase a motor for surgery. It is CE marked in class IIa for a different indication for use than the one we want.
We want to connect our own instruments to this motor and use it for our own indication of use. It is class IIb. We want to mark it CE for pre clinical tests. The main standard to undertake is 60601-1.
We've never had this case before. What we plan to do is:
-redo the risk analysis with our own IFU and instrument,
-produce the risk management proofs with the following cases
1.a sub set of risks are mitigated by the proofs given by the manufacturer of the motor
2.the other risks shall be mitigated with our own proofs
Any comments on this plan ?
Thanks a lot.