UltraLinq Healthcare Solutions

UltraLinq Healthcare Solutions

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QP-7.3.0-018 Post Market Clinical Follow Up Rev 0

This document is intended to describe how UltraLinq Healthcare Solutions carry out Post-Market Clinical Follow-up (PMCF) studies in order to fulfil Post-Market Surveillance (PMS) obligations according to Section 3.1 of Annex II, to requirements of Annex X of Directive 93/42/EEC. and paragraph 8 of Article 15 of Directive 93/42/EEC and MEDDEV 12.2/12 which spells out the provisions of Article 15 that are not applicable to clinical investigations conducted using CE-marked devices within their intended use.