In diagnostics, trust is the product. RDi USA has published how its certifications map onto the US regulatory framework its customers answer to.
The company's ISO 13485 medical-device quality system supports FDA Quality System Regulation expectations (21 CFR Part 820); ISO 27001 underpins enterprise information security; and its electronic records are built to be 21 CFR Part 11-ready through +CURA. Collection and handling workflows are designed around CLIA laboratory requirements, and shipping meets UN3373.
Every one of the twelve platforms inherits the same compliance spine — you don't re-earn trust per program.
RDi USA is working towards the full set of US standard requirements as it scales, and makes its compliance documentation available for procurement and security review.