IVDMA:

We assist IVDMIA companies.
What is IVDMIA?
An In Vitro Diagnostic Multivariate Index Assay (IVDMIA) is a diagnostic algorithm that combines multiple variables in a manner that cannot be independently derived or verified by the end user. Examples include diagnostic devices that use gene expression profiling, combine results from multiple immunoassays, and devices that integrate patient demographics and genotypes of multiple genes. (Ref. FDA draft guidance July 2007)

We have assisted many IVDMIA manufacturers in preparing technical specifications for FDA pre market submissions (510ks) and in establishing Quality System Regulation compliant quality systems. Our experience and proven sample procedures and specifications simplify the implementation of quality systems and assure compliant solutions.