ISO 13485 Quality Management System
Medical device customers need traceable processes, documented inspection, and audit-ready records. Our ISO 13485 certification supports prototypes through production volumes for instruments, housings, and implant-adjacent components.
System Coverage
- Device history record (DHR) support per lot
- Risk-based inspection planning for critical dimensions
- Clean handling and contamination control procedures
- Supplier control for implant-grade and biocompatible materials
- Change control and revision management
- Complaint handling and CAPA documentation
Documentation You Receive
- ISO 13485 certificate copy on request for vendor qualification
- Inspection records with lot/batch traceability
- Material certifications for implant-grade alloys and PEEK
- CoC and dimensional reports for regulatory submissions
- First Article Inspection for new device revisions
Industries Served
- Surgical instruments
- Diagnostic equipment
- Implant-adjacent components
- Medical robotics
- Dental & orthopedic devices
Audit & Maintenance
Certified to ISO 13485:2016. We provide full traceability, inspection records, and material certifications for medical device customers and their regulatory files.
Frequently Asked Questions
Are you ISO 13485 certified?
Yes. We hold ISO 13485 certification and provide certificate copies for vendor portals. We also supply full lot traceability, inspection records, and material certifications for medical device customers.
Can you machine implant-grade titanium and stainless?
Yes. We machine Ti-6Al-4V ELI, 316LVM, and other medical-grade materials with mill certifications and documented handling procedures.
Do you support FDA or MDR documentation needs?
We provide lot traceability, inspection records, and material certs that support your device history file (DHF/DHR). We do not act as the legal manufacturer — documentation scope is per your quality agreement.
Need ISO 13485 Documentation?
Specify quality requirements on your drawing or RFQ — we'll confirm scope and include the right reports in your quote within 24 hours.
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