Quality And

Regulatory

We define excellence as the intersection of quality and innovation. We are fully committed to providing innovative medical devices and services that meet industry standards and regulatory requirements through effective QC processes and safe work environments.

We Define

Excellence

Quality Comes Standard With Every Product

Quality is our priority! We are making healthcare better by providing timely and accurate medical devices and services that meet regulatory requirements through an effective quality system and a safe work environment.

All medical devices manufactured by Argon Medical Devices, Inc. have been designed, developed and manufactured using standards specified by ISO 13485:2016 and the U.S. Food and Drug Administration.

CERTIFICATES

If you have questions on regulatory documentation, global registrations, quality agreements, certifications or other compliance questions, please let us know.

For concerns about product performance, contact our Customer Feedback group.

Summary of Safety & Clinical Performance Documents (SSCP)

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