At HY Metals, we are excited to announce we are currently undergoing ISO 13485 certification for Medical Device Quality Management Systems, with completion expected by mid-November. This important certification will further strengthen our capabilities in manufacturing precision medical components for our global healthcare clients.
Expanding Our Multi-Industry Manufacturing Expertise
While we are enhancing our medical quality systems, it’s important to note that HY Metals serves diverse industries including:
- - Aerospace – structural components and mounting brackets
- - Automotive – custom fittings and enclosures
- - Robotics & Automation – precision joints and actuator parts
- - Electronics – housings and heat dissipation components
- - Medical – instrument parts and device components
Our Manufacturing Specialization
We specialize in custom component manufacturing through:
- - Precision Sheet Metal Fabrication
- - CNC Machining (milling and turning)
- - Plastic Component Production
- - 3D Printing (prototyping and low-volume production)
Why ISO 13485 for Medical Components?
The ISO 13485 certification demonstrates our commitment to:
- - Enhanced traceability for medical-grade materials
- - Stricter process controls for medical components
- - Robust documentation and quality management
- - Consistent quality for critical healthcare applications
Building on Quality Foundations
Since achieving ISO 9001:2015 certification in 2018, we have continuously improved our processes across all manufacturing sectors. The addition of ISO 13485 specifically addresses the rigorous requirements of medical device component manufacturing while maintaining our high standards for all industry clients.
Our Medical Component Capabilities
For healthcare applications, we manufacture:
- - Surgical instrument components
- - Medical device structural parts
- - Diagnostic equipment enclosures
- - Laboratory instrument parts
Quality Without Compromise
Our certification process includes:
- - Comprehensive system implementation
- - Rigorous internal auditing
- - Enhanced documentation protocols
- - Staff training and competency development
Partner with a Versatile Manufacturing Expert
Choose HY Metals for:
- - Multi-industry manufacturing expertise
- - Quality certifications including ISO 9001 and upcoming ISO 13485
- - Rapid prototyping and production capabilities
- - Technical support across various manufacturing technologies
Commitment to Excellence
The pursuit of ISO 13485 certification reflects our dedication to serving the specific needs of medical industry clients while maintaining our position as a trusted manufacturing partner across multiple sectors.
Contact us today to discuss your component manufacturing needs – whether for medical applications or any other industry requiring precision custom parts.
ISO13485 MedicalComponents PrecisionMachining CNCMachining SheetMetalFabrication QualityManufacturing
Post time: Oct-22-2025