Svensk definition
Förfarande för provning, utvärdering och godkännande för bruk av apparater, utrustningar och maskiner. Godkännandet utfärdas av en inom användningsområdet ansvarig myndighet.
Device Approval
Godkännande av utrustning
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