MDSAP Multi-Jurisdiction Audit
MDSAP is a single regulatory audit that satisfies the requirements of multiple medical device regulatory authorities including the U.S. FDA, Health Canada, Australia's TGA, Brazil's ANVISA, and Japan's MHLW/PMDA. The RX1's manufacturer operates under an MDSAP-recognised quality system.
- Single audit recognised across five jurisdictions
- Aligned with ISO 13485 quality management requirements
- Required for entry to Health Canada and TGA markets
Full documentation available on request. Contact support@revogenlab.com.
