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Regulatory
Quality and Regulatory Compliance
PBM's manufacturing facility is a registered FDA Medical Device Establishment operating under current Good Manufacturing Practices (cGMP). PBM's quality system is certified under ISO 13485:2003 (EN ISO 13485:2012) and is periodically inspected by third party auditors to verify conformity with these standards and regulations, further assuring high quality products and services. PBM markets products with U.S. FDA 510(k) clearance, Canadian Medical Device Conformity Assessment System, European Union CE mark and other regulatory approvals and registrations as necessary in various countries.

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