Diagnostics & IVD Consulting
IVD, LDT, CDx, NGS and software diagnostic strategy across FDA and EU IVDR.
Diagnostics & IVDs
IVDs, LDTs, companion diagnostics, NGS, software-only Dx.
How we serve Diagnostics & IVDs.
Precision medicine has established diagnostics as its foundation for clinical decision making and regulatory reform. Our work supports all types of diagnostics (IVD, LDT, Companion Diagnostic, NGS, Molecular Assays, Immunoassays, Software Only Diagnostic) through programs in the US (FDA), EU (EU IVDR), and globally (CLIA/CAP).
We link the two worlds that rarely have common ground. The world of analytical validation, clinical performance, specimen handling, intended use, risk classification, labeling, quality system, and regulatory submissions. Ultimately we provide a diagnostics compliance program with scientific credibility, regulatory compliance, and commercial feasibility.
FDA 21 CFR Part 809
FDA 510(k), De Novo and PMA pathways
FDA LDT Final Rule
EU IVDR 2017/746
CAP / CLIA
ISO 13485:2016
ISO 14971:2019
IMDRF SaMD / clinical evaluation principles
Where we typically engage with Diagnostics & IVDs clients.
Service detail
EU IVDR Compliance
Risk classification, performance evaluation, GSPR and Notified Body readiness.
FDA De Novo Classification
Novel diagnostic pathway strategy when no appropriate predicate exists.
Quality Management Systems
ISO 13485, design controls, CAPA and diagnostic lifecycle quality systems.