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Clinical Investigation Plans The Role Of MDCG 2024-3 In The Context Of EU MDR Annex XV ISO 14155

The Medical Device Coordination Group (MDCG) published the new 2024-3 guidance document relating to clinical investigations of medical devices. How.

United statesMatthias finkLeslie hammermMuna kebedeLeslie hammermuellerTeam gmbD product serviceEuropean unionClinical focus team north americaEuropean commissionDevice coordination groupGood clinical practiceMedical device coordination groupClinical investigation planExisting guidance andNotified bodies

Guardant360 CDx Gains European Union Certification for Tumor Profiling in Solid Tumors

Guardant360 CDx received In Vitro Diagnostic Regulation certification for tumor mutation profiling in solid tumors and for companion diagnostic indications in NSCLC and breast cancer.

Helmy eltoukhyPeter faschingCancer centerD product serviceBreast cancer centerGynecological cancer centerNational comprehensive cancer networkEuropean unionGuardant healthVitro diagnostic regulationNational comprehensive cancerComprehensive cancer center

Guardant Health Receives EU IVDR Certification for Guardant360® CDx Liquid Biopsy for Tumor Mutation Profiling Across All Solid Cancers and Companion Diagnostic Indications

Guardant Health Receives EU IVDR Certification for Guardant360® CDx Liquid Biopsy for Tumor Mutation Profiling Across All Solid Cancers and Companion Diagnostic Indications
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Emilia romagnaPeter faschingDino amadoriHelmy eltoukhyNicola normannoBreast cancer centerD product serviceEuropean union in vitro diagnostic regulationNational comprehensive cancer networkGuardant health incGuardant healthGynecological cancer centerRomagna institute for the study of tumorsExchange commissionCancer centerEuropean union

Guardant Health, Inc : Guardant Health Receives EU IVDR Certification for Guardant360 CDx Liquid Biopsy for Tumor Mutation Profiling Across All Solid Cancers and Companion Diagnostic Indications

Blood-based test for comprehensive genomic profiling of solid cancers meets requirements under stricter EU In Vitro Diagnostic Regulation IVDR certification from TÜV SÜD enables broader adoption

Emilia romagnaMichael weistNicola normannoZarak khurshidDino amadoriHelmy eltoukhyPeter faschingGynecological cancer centerCancer centerGuardant health incNational comprehensive cancer networkExchange commissionEuropean union in vitro diagnostic regulationBreast cancer centerGuardant healthD product service

Drivers with certain tyres warned they will need to drive 3mph slower

Drivers with certain tyres warned they will need to drive 3mph slower
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