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: Quality<br />
Assurance<br />
• <strong>Notified</strong> Body performs audit of the<br />
manufacturer‘s quality assurance system<br />
• QA-system in accordance with ISO 13485<br />
(requirements for medical devices). (ISO 9001<br />
(general QA) is optional <strong>and</strong> not advisable)<br />
ISO 9001<br />
ISO 13485<br />
Not required<br />
for Medical<br />
Devices<br />
Specific<br />
requirements<br />
(Recommended)<br />
S19
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