Quality & Regulatory System
At Albert, quality and compliance are at the core of everything we do. Our Quality Management System (QMS) is designed to meet stringent regulatory requirements and industry standards, ensuring product safety, reliability, and performance.
US FDA Registration
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 Standard
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.
View our ISO Certificate