Documentation Benchmarks: Navigating FDA 510(k) vs. EU IVDR for HLA...

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2026-01-07 08:45:51 -

Documentation Benchmarks: Navigating FDA 510(k) vs. EU IVDR for HLA Typing (2026)

As we progress through 2026, the regulatory landscape for transplant diagnostics has reached a point of peak complexity. For manufacturers of HLA typing kits, the divergence between the United States’ "Substantial Equivalence" model and Europe’s "Conformity Assessment" framework requires a dual-track documentation strategy. Understanding these specific requirements is...

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