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Glossary

Justification Table

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In relation to Policy 70, to be completed by the Applicant to justify the proposed redaction of CCI.

Other glossary definitions

I

ISO 13485

ISO 13485 is a Quality Management System (QMS) standard designed specifically for medical devices, and…

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E

EMA HTA Parallel Scientific Advice

When developing a medicinal product, two milestones are of importance for making its path to…

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