Act or omission of an act by the operator or user of a medical device as a result of conduct which is beyond any means of risk control by the manufacturer.
Act or omission of an act by the operator or user of a medical device as a result of conduct which is beyond any means of risk control by the manufacturer.
Upon completion of a clinical trial, the sponsor is required to prepare a detailed report…
View definitionThe Early Dialogue Committee (EDC) is constituted for a specific product and the members will…
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