Premier Perspectives The blog for insider insights in clinical development Clinical Research: Phase 1 - Phase 4 IVDR Survival Guide Part 2: Preparing for the NB Bottleneck By Matthew Nowland May 18, 2022 Featured Posts Clinical ResearchPhase 1 - Phase 4 IVDR Survival Guide Part 1: A Deep Dive into Classification, Clinical Evidence, and Performance Requirements By Matthew Nowland May 18, 2022 Clinical ResearchPhase 1 - Phase 4 FAQs: In Vitro Diagnostic Medical Device Regulation By Matthew Nowland March 14, 2022 Recent Posts By expertise area All expertise areas Medical DeviceRare DiseaseOncology & HematologyDiagnosticsDigital TherapeuticsMedTechPediatricsNeuroscienceAnalgesiaDermatologyOtherCOVID-19Cell & Gene TherapyWomen's HealthReal-World & Late PhaseCareers By functional area All functional areas Development StrategyClinical Research: Phase 1 - Phase 4ConsultingData Management & BiostatisticsFunctional Service Provider (FSP)Global ComplianceMedical and Regulatory AffairsPatient and Stakeholder EngagementProject ManagementQualityReal-World Science and Late PhaseSafety/PharmacovigilanceStudy DesignStudy Start-UpOtherCOVID-19Product Development Clinical ResearchPhase 1 - Phase 4 The Key to Streamlining Regulatory Approval for IVDs By Matthew Nowland February 15, 2022 × ALSO OF INTERESTGene Therapy 101: From the 1960s to TodayKey Considerations When Designing a Phase 1...7 Questions About Clinical Evaluations for MDR
