Quality & Regulatory
FDA 21 CFR Part 820
Independant and constantly audited production sites in Germany and the USA.
hg medical runs on both production sites completely independent quality management systems. Both hg medical subsidiaries are ISO 13485:2016 certified. Of course both sites act according FDA 21 CFR Part 820 and have seen full FDA audits.
Our internal audits are performed ongoing and regulary. In addition to that, we see multiple customer audits every year. When you enter our production halls, you feel the sense for quality every single time. As an OEM, you know this all is not easy to explain in words. Come and test us!