Certifications & Compliance
Certifications & Compliance
At Enzo Dental, we are committed to ensuring the highest quality, safety, and performance standards for our products. We adhere to internationally recognized certifications and regulatory requirements to provide our customers with reliable and compliant dental instruments.
Our Certifications
- ISO 9001: Quality Management System (QMS) certification ensuring our manufacturing processes meet the highest quality standards.
- ISO 13485: Medical Devices Quality Management certification, ensuring that our instruments meet all necessary regulatory requirements for medical device manufacturing.
- CE Certification: Conformity with European health, safety, and performance requirements, allowing our products to be sold within the European Union.
Our Compliance Practices
We maintain strict compliance with industry regulations, ensuring that all products are safe, effective, and reliable for clinical use. Our compliance practices include:
- Use of high-quality, corrosion-resistant stainless steel for all dental instruments.
- Sterilization-ready materials for safe clinical use in all healthcare settings.
- Regular internal and external audits to ensure compliance with quality standards and legal requirements.
Certifications for Our Products
ISO 9001 - Quality Management Systems
This certification ensures that our products and services meet consistent quality standards, and our processes are continuously improving to meet customer expectations.
ISO 13485 - Medical Devices Quality Management
ISO 13485 ensures that our dental instruments meet all the necessary requirements for medical devices, ensuring they are safe and reliable in clinical practice.
CE Certification
Our products are CE marked, indicating they conform to European health, safety, and environmental protection standards, allowing them to be marketed within the EU.