Why Raw Material Sourcing is Critical for ISO 13485 Compliance
Traceability is Key For IVD manufacturers, every component must be traceable. Using generic, unbranded strips is a major non-conformance risk. Full Documentation Due Bio provides full CoA (Certificate of Analysis) and lot traceability for every pack of Universal Strips. Our manufacturing process aligns with ISO 13485 standards, simplifying your CE/FDA submission process.