Hi All,
If the manufacturer of a class I medical device which is electrically powered and for use in private homes fails to test their product to the Home Healthcare standard 60601-1-11 before self declaring and releasing for sale, what would be the consequences. Would anybody notice, and if they did what would the consequences be should the omission be reported to the competent authorities.
Jo
If the manufacturer of a class I medical device which is electrically powered and for use in private homes fails to test their product to the Home Healthcare standard 60601-1-11 before self declaring and releasing for sale, what would be the consequences. Would anybody notice, and if they did what would the consequences be should the omission be reported to the competent authorities.
Jo