6102 Victory Way, Indianapolis, IN 46278, USA

Regulatory Compliance

Quality & Regulatory Downloads

International Regulatory Compliance Information

We are US FDA registered, compliant with 21 CFR Part 820, Quality System Regulation, and ISO 13485 certified Manufacturers.

We assist our customers with all of their regulatory requirements.

Indianapolis ISO 13485 Quality System Certificate PDF
U.S. Food and Drug Administration BiomericsATL Indianapolis Registration Number: 1833117
BiomericsATL Costa Rica Registration Number: 3014246639
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Europe EC Certificates EC Certificate CE 6674 PDF
EC Certificate CE 597141 PDF
Health Canada Canada Establishment License PDF
Health Canada
BSI Maintained Certificates ISO 13485:2016 PDF
EC Certificate CE 66745 PDF
EC Certificate CE 597141 PDF