In diagnostics, trust is the product. Our quality and security systems aren't a checkbox — they're the reason labs, payers and programs can build on us.
Our international certifications map directly onto the US regulatory framework your organization answers to.
RDi USA is working towards the US standard requirements.
| Our certification | What it covers | US requirement it supports |
|---|---|---|
| ISO 13485 | Medical device quality management | FDA QSR / 21 CFR Part 820 |
| ISO 27001 | Information security management | Enterprise security & data protection |
| ISO 9001 | Quality management systems | Operational quality baseline |
| ISO 14001 | Environmental management | Sustainability & ESG |
| UN3373 | Biological substance shipping | DOT / IATA transport rules |
| 21 CFR Part 11-ready | Electronic records & signatures | FDA-regulated e-records (via +CURA) |
Manufacturing and quality systems built to support FDA-regulated diagnostics.
Collection and handling designed around CLIA lab requirements.
Information security managed under a certified ISO 27001 program, with encryption and access controls.