What documents may be included in PMCF / PMS translation workflows?

PMCF / PMS translation workflows may cover PMCF plans, PMCF evaluation reports, PMCF surveys, registry content, PMS plans, PMS reports, PSURs, periodic safety updates, complaint summaries, incident reports, vigilance correspondence, trend analyses, CAPA inputs feeding post-market files and supporting evidence updates. They may also extend to CER inputs, SSCP updates, IFU revisions and labelling changes triggered by post-market findings. The exact scope depends on device class, regulatory pathway and the manufacturer's post-market strategy. AbroadLink scopes each project around the documents actually involved and applies risk-based workflow selection per document type and sensitivity.