Aspen Medical Products, inc.

Regulatory Compliance Information

Quality Management Systems

  • US FDA Good Manufacturing Practice (GMP)

    We are fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations and are registered with them and the State of California to manufacture medical devices.

  • Europe & International

    We are not ISO certified as all of our products are classified as Class I.

Product Certifications and Approvals