Quality

Built on Standards. Designed for Trust.

BETA Biomed takes pride in the quality of goods and services provided to our customers. Our objective is complete conformance to regulatory and customer requirements.

FDA CGMP (CFR 21)
ISO 13485
ISO 14971
510(k) Clearance

BETA Biomed is committed to producing quality rather than quantity. We operate a preventive quality system that identifies and resolves issues at the point of occurrence, eliminating them from the final product. We are continually improving and maintaining the effectiveness of our quality system.

Certifications

FDA Registration

FDA registered facility, licensed by the Texas Department of State Health Services.

ISO 13485 Certificate

Certified Quality Management System for medical devices.

Certificate to Foreign Government

Export documentation confirming compliance and device status.

Our Quality Approach

Preventive System

Design-out defects at the source using documented controls.

Root-Cause @ Source

Resolve issues where they occur to protect the final product.

Traceability

Clear records from intake to shipment for every lot and device.

Continuous Improvement

KPIs, CAPA loops, and periodic audits to raise the bar.

Looking for certificates or have a compliance question?