FDA Compliance (510(k) Cleared Device)
roclub’s medical device, rTOP, is cleared by the FDA under the 510(k) pathway, confirming that it is safe, effective, and substantially equivalent to a legally marketed predicate.
- Fully compliant with 21 CFR Part 820 (FDA Quality System Regulation)
- Comprehensive documentation of design controls, risk management, verification & validation
- Active post-market surveillance and complaint handling system