Assess and designate Notified Bodies - TOPRA
Assess and designate Notified Bodies - TOPRA
Assess and designate Notified Bodies - TOPRA
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Conformity assessment<br />
<strong>Notified</strong> Body Involvement<br />
The higher the risk of the device, the more<br />
the <strong>Notified</strong> Body has to be involved<br />
Design Dossier Review<br />
Technical File Review<br />
Annex II design output<br />
Technical File review<br />
Annex II design output; Annex V no design output<br />
QMS <strong>Assess</strong>ment<br />
Sterility & Metrology Technical Review<br />
QMS <strong>Assess</strong>ment<br />
Medical Device NB<br />
Class III<br />
Class IIb<br />
Class IIa<br />
Class I<br />
ISO 13485<br />
31
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