Industry-Leading Standards

Compliance & Standards

Our commitment to excellence is backed by rigorous certifications, comprehensive testing protocols, and unwavering adherence to international safety standards.

25+
Years Experience
100%
Compliance Rate
50+
Certifications
10K+
Tests Completed
Our Certifications

Industry-Leading Certifications

We maintain the highest levels of certification across all international standards to ensure your safety and confidence.

ISO 9001:2015

Quality Management Systems certification ensuring consistent quality in all our products and services.

Internationally Recognized

ISO 13485:2016

Medical Devices Quality Management specifically designed for healthcare and medical shielding applications.

Medical Grade Standard

NRC Compliance

Full compliance with Nuclear Regulatory Commission standards for radiation protection and shielding.

Federal Regulation

JCI Accreditation

Joint Commission International accreditation for healthcare quality and patient safety standards.

Healthcare Gold Standard

EPA Standards

Environmental Protection Agency compliance for safe disposal and environmental responsibility.

Environmentally Safe

CE Marking

European Conformity marking for products meeting EU health, safety, and environmental requirements.

EU Certified
Quality Assurance

Our Quality Assurance Process

Every product undergoes rigorous testing and inspection to ensure it meets our exacting standards.

Material Testing

Every raw material is tested for purity, density, and radiation attenuation properties before use.

Manufacturing Control

ISO-controlled manufacturing processes with real-time monitoring and automated quality checkpoints.

Radiation Testing

Full spectrum radiation testing using calibrated equipment to verify shielding effectiveness.

Final Certification

Comprehensive documentation and certification package delivered with every product.

Regulatory Compliance

Meeting Global Standards

Our products comply with all major international regulatory bodies and standards organizations, ensuring safe and effective radiation protection worldwide.

United States

FDA 21 CFR Part 820, NRC 10 CFR Part 20, HIPAA Compliance

European Union

MDR 2017/745, RoHS Directive, WEEE Compliance

International

IEC 60601, IAEA Safety Standards, WHO Guidelines

Compliance Checklist

Documentation

Comprehensive Testing & Reports

Every product comes with detailed documentation for regulatory compliance and facility auditing purposes.

Test Certificates

Detailed radiation attenuation measurements with calibration traceability

Material Data Sheets

Complete chemical composition, physical properties, and safety data

Compliance Reports

Third-party audit reports and regulatory compliance documentation

Installation Guides

Detailed specifications, installation procedures, and maintenance protocols

FAQ

Frequently Asked Questions

Find answers to common questions about our compliance standards and certifications.

Ready to Ensure Your Compliance?

Contact us today to request documentation, discuss your compliance requirements, or schedule a consultation with our regulatory experts.