ISO 9001:2015
ISO 13485:2016
FDA Registered
LFGB
REACH
RoHS
What Our Certifications Mean for You
Not just logos on a wall — each certification represents a system that protects your product and your customer.
ISO 9001:2015
Quality Management System. Covers all manufacturing processes from order intake to delivery. Annual surveillance audits by accredited registrar.
ISO 13485:2016
Medical Device Quality Management. Design controls, risk management, traceability, and sterilization compatibility for medical-grade silicone parts.
FDA 21 CFR 177.2600
Rubber articles intended for repeated use in contact with food. Extractive limitations in n-hexane and water. Material formulations on file and verifiable.
LFGB (EU Food Contact)
German Food & Feed Code. Stricter than FDA — includes sensory (taste/odor) testing and overall migration limits. Required for EU market access.
REACH (EC 1907/2006)
EU chemical regulation. All compounds tested for SVHC (Substances of Very High Concern). None of our formulations contain substances on the candidate list.
RoHS 3 (2015/863)
Restriction of Hazardous Substances. No lead, mercury, cadmium, hexavalent chromium, PBB, PBDE, or four specified phthalates in any compound.
4-Stage Quality Control
Every order passes through four inspection gates. No shortcuts.
Incoming Material
Raw material tested for hardness, specific gravity, and visual defects. Material certificate verified before production release.
First Article
First 5–10 parts fully inspected: dimensions, hardness, visual, and function. Production released only after FAI approval.
In-Process
AQL sampling every 2 hours during production. Dimensional check, visual, and functional test. Data logged for traceability.
Final Inspection
100% visual inspection + AQL dimensional sampling. Inspection report and material certificate packed with shipment.
In-House Testing Capabilities
We test in-house for speed and control. Third-party lab testing available on request.
Dimensional
- Digital caliper (0.01mm)
- Optical comparator
- CMM (coordinate measuring)
- Go/no-go gauges
Material
- Shore A / OO durometer
- Density / specific gravity
- Tensile strength & elongation
- Tear resistance
Performance
- Compression set (ASTM D395)
- Aging & heat resistance
- Low-temperature flexibility
- Ozone resistance
Full Traceability, Every Batch
Every shipment includes a lot card linking your parts to the raw material batch, production date, press number, operator, and inspection results. If there’s ever a field issue, we can trace back to root cause within hours.
Need Documentation for Your Audit?
We provide certification copies, material declarations, and inspection reports on request. Send us your requirements.