Device Approval

Godkännande av utrustning

Svensk definition

Förfarande för provning, utvärdering och godkännande för bruk av apparater, utrustningar och maskiner. Godkännandet utfärdas av en inom användningsområdet ansvarig myndighet.

Engelsk definition

Process that is gone through in order for a device to receive approval by a government regulatory agency. This includes any required preclinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance. It is not restricted to FDA.

Svenska synonymer

Typgodkännande Godkännande av ny utrustning

Engelska synonymer

Approval, Device Approvals, Device Device Approvals Device Approval Process Approval Process, Device Approval Processes, Device Device Approval Processes Process, Device Approval Processes, Device Approval Food and Drug Administration Device Approval Process New Device Approval Approval, New Device Approvals, New Device Device Approval, New Device Approvals, New New Device Approvals Food and Drug Administration Device Approval New Device Approval Process