Quality & Certifications
Trust, front-loaded
In regulated manufacturing, credentials are table stakes. Here are ours — and the systems behind them.
Certifications & compliance
Certified for regulated work
✅
ISO 13485
✅
FDA Registered
✅
ISO 9001
✅
IATF 16949
✅
ITAR Compliant
✅
MIL-SPEC / MIL-STD
✅
CMMC Level 1
✅
ISO 14971 Risk
Systems & validation
Audit-ready by design
- Validation: IQ / OQ / PQ
- DFMEA & PFMEA analysis
- Statistical Process Control (SPC)
- On-site quality control laboratory
- Full traceability & documentation
- ISO 14971 risk management
Customer benefits
- Reduced quality & compliance risk
- Faster validation & regulatory approvals
- Confidence serving highly regulated markets
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