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EU IVDR · Technical · Performance · Risk EU IVDR Complete Bundle The three kits together, already cross-referenced, plus six documents that are not sold anywhere else. Everything a complete IVDR submission needs, in one download. €999 VAT calculated at checkout Get the kit 31 templates · Word and ExcelSave €178 · instant download The…
EU IVDR · Annex XIII · Annex III · MDCG 2022-2 EU IVDR Performance Evaluation Kit Three reports, one evaluation, and the post-market loop that closes it — the evidence architecture the IVDR requires and the MDR does not have. €399 VAT calculated at checkout Get the kit 11 Word templates · Annex XIII Part…
EU IVDR · Annex II · Annex III · Annex IV EU IVDR Technical Documentation Kit The full Annex II technical file for an in vitro diagnostic, in the order the Regulation itself sets — so a completeness check runs straight through instead of stopping on the first section. €429 VAT calculated at checkout Get…
EU IVDR · ISO 14971 · ISO/TR 24971 · Annex I IVDR Risk Management Documentation Kit A risk file that treats a wrong result as the hazard it actually is — because for a diagnostic the harm is indirect, and a hazard library written for therapeutic devices does not reach it. €349 VAT calculated at…
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