Arbelos anticipates future regulatory challenges and proactively assists clients in transitioning their LDTs to IVDs, streamlining the process and accelerating time-to-market
Arbelos offer the regulatory support
FDA Submission type plan
FDA 510K
PMA
Q-Submission
Besides companion diagnostic products, our expert also specialize in FDA submission for point of care (POC) device and products.
Contact experts for first free regulation analysis on your product: Service@arbelosdx.com