Manufacturing Standards
Cuddy Proton Tech operates at the intersection of advanced physics and industrial precision. Our manufacturing protocols are engineered to exceed global regulatory requirements, ensuring that every OEM component delivers absolute reliability in the clinical environment.
Fabrication Certifications
Industrial Specifications
ISO 13485
Medical Device ManufacturingThe definitive standard for medical device production. This governs our entire internal manufacturing lifecycle—from raw material receipt to precision machining—ensuring consistent clinical-grade output.
IEC 60601
Electromechanical SafetyA rigorous framework for the essential performance of medical electrical equipment. We engineer gantry drives and beam monitoring systems to withstand the electromagnetic demands of high-energy particle therapy.
ISO 9001
Manufacturing QualityThe backbone of our operational consistency. This standard regulates our fabrication tolerances and precision engineering workflows, guaranteeing that every unit meets the same high-performance specifications.
Our Manufacturing Guarantee
Every component we fabricate—from high-field magnetic coils to specialized gantry bearings—is critical to patient outcomes. We maintain total production oversight and utilize serialized in-house testing to guarantee absolute mechanical and clinical integrity.