100 W. Industrial Rd., Addison, IL 60101 USA

Regulatory Compliance

Leading the way in American-made medical devices for women's health.

Quality & Regulatory Downloads and 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 1833117 Search FDA
Europe EC Certificates EC Certificate CE 66745 PDF
EC Certificate CE 597141 PDF
Health Canada Quality Sys. Cert. MD560630 PDF
Health Canada
Social Media Policy Reference Document PDF
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