Quality & Regulatory System
US FDA Good Manufacturing Practice (GMP):
We are compliant with 21 CFR Part 820, US FDA Quality Systems Regulations. View our Establishment Registration on the FDA website fda.gov Our registration number is 1037752.
Compliance with ISO 13485 standards:
We ensure alignment of our QMS to quality standards and regulatory requirements. Our QMS is implemented across our organization and verified by an independent third-party-certified body for ISO 13485.