Assess and designate Notified Bodies - TOPRA
Assess and designate Notified Bodies - TOPRA
Assess and designate Notified Bodies - TOPRA
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Conformity <strong>Assess</strong>ment<br />
Procedures<br />
Technical Documentation<br />
I I* IIa IIb III IIa IIb III<br />
Annex VII<br />
EC-<br />
Declaration<br />
of<br />
Conformity<br />
Annex III<br />
EC - Type Examination<br />
Annex II<br />
Full Quality<br />
Assurance<br />
- ISO 13485<br />
Annex II<br />
Full Quality<br />
Assurance<br />
+ Design<br />
Examination<br />
I<br />
I* IIa IIb<br />
Annex IV<br />
I* IIa IIb III I* IIa IIb<br />
Annex V<br />
Annex VI<br />
- ISO 13485<br />
- Design<br />
Dossier<br />
Examination<br />
EC-Verification<br />
- each device<br />
- samples<br />
QA Production<br />
- ISO 13485<br />
QA Product<br />
- ISO 13485<br />
CE<br />
CE + Number of <strong>Notified</strong> Body
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