Good morning,
I am working with a client who has a medical device that is internally powered from a battery, but this battery is charged from the mains, potentially with the patient attached.
I have two questions:
1) I am assuming that this needs to be classed as a Class II medical device,
2) If the charging unit is 60601-1 certified what MOPPs would need to be incorporated.
I hope that all makes sense.
Thank you in advance.
I am working with a client who has a medical device that is internally powered from a battery, but this battery is charged from the mains, potentially with the patient attached.
I have two questions:
1) I am assuming that this needs to be classed as a Class II medical device,
2) If the charging unit is 60601-1 certified what MOPPs would need to be incorporated.
I hope that all makes sense.
Thank you in advance.