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 13485:2016 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 13485:2016.