Quality Without Compromise
At NovaTech Scientific, quality is not just a standard—it's our foundation. Every medical device we manufacture undergoes rigorous quality control processes to ensure safety, reliability, and regulatory compliance.
Certifications & Approvals
FDA Registered
All products are manufactured at our FDA-registered facility in compliance with U.S. Food and Drug Administration regulations for medical devices.
ANVISA Approved
Full regulatory approval from Brazil's National Health Surveillance Agency, ensuring compliance with Brazilian healthcare standards.
INMETRO Certified
Brazilian national certification from the National Institute of Metrology, Quality and Technology for quality and safety standards.
SGS Audited & Approved
Third-party verification by SGS, the world's leading inspection, verification, testing, and certification company.
Our Quality Practices
Vertically Integrated Manufacturing
Every step from design to final packaging occurs under one roof, ensuring complete control over quality at every stage.
Full Batch Traceability
Complete documentation and tracking from raw materials to finished product, enabling rapid response to any quality concerns.
UDI Compliance
All products feature Unique Device Identification in compliance with FDA requirements for medical device tracking.
In-House Testing Facility
Our facility includes a full operating room for product development, testing, and validation in realistic surgical conditions.
Continuous Improvement
Regular internal audits and process reviews ensure our quality systems evolve with industry best practices.
Supplier Quality Management
Rigorous qualification and ongoing monitoring of all raw material suppliers to maintain consistent quality inputs.
Made in the USA
All NovaTech Scientific medical devices are designed, engineered, and manufactured at our headquarters in Boca Raton, Florida. Our vertically integrated approach means we control every aspect of the manufacturing process, from initial concept to final sterilization and packaging.
This commitment to domestic manufacturing ensures the highest quality standards, shorter lead times, and the flexibility to respond quickly to customer needs.
Learn More About Us
Request Documentation
Need certificates of compliance, product specifications, or quality documentation? Contact our quality assurance team.