Laboratory Developed Test (LDT) vs IVD Validation Workflow
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IVD-Regulation (IVDR)
- IVDR compliant instruments*
- IVDR compliant software*
- IVDR compliant reagents
- E-book
- Future proofing your flow cytometry panel under IVDR
- In-house IVD FCM panel or not: it depends
- Building IVDR compliant panels for haematological disorders
- Impact of the new EU IVD-Regulation on the daily life of the clinical Flow cytometry laboratory webinar
- Laboratory Developed Test (LDT) vs IVD Validation Workflow
- Meet the Expert — Maurizio Suppo, PhD
- Potential Impacts of EU IVD-Regulation on the Clinical Flow Cytometry Lab
- IVD-R Annex I Global Safety and Performances Requirements (GSPR). A New Set of Requirements for Clinical Laboratories Performing Laboratory Developed Tests
- IVD-R: Key Considerations to Validate a Flow Cytometry Assay According to ISO 15189 Requirements