Assess and designate Notified Bodies - TOPRA
Assess and designate Notified Bodies - TOPRA
Assess and designate Notified Bodies - TOPRA
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
Tasks for <strong>Notified</strong> <strong>Bodies</strong><br />
• Pre-market assessment for medium or high risk<br />
devices<br />
– <strong>Assess</strong> quality systems, production <strong>and</strong> sterility<br />
– Review technical files <strong>and</strong> design dossiers<br />
• Ongoing evaluation<br />
– Quality Management System, Post-Market<br />
Surveillance <strong>and</strong> Vigilance<br />
– Changes to design<br />
– IVD batch verification<br />
• Re-evaluation <strong>and</strong> re-certification<br />
– Audit cycle, multi-site reviews<br />
– State of art in design<br />
8
Change language