Medical Device Tooling
ISO-ready tooling and process documentation for regulated manufacturing — built for consistency, traceability, and validation.
Typical response time: within 24 hours.
Regulatory & Technical Capabilities
Design Controls
Aligned with ISO 13485 and FDA expectations.
Material Compliance
USP Class VI, ISO 10993 guidance support.
Documentation
Traceability packs, lot control, device history records.
Process Validation
DQ/IQ/OQ/PQ with protocols and reports.
Metrology
GR&R, capability studies, and inspection plans.
Packaging & Sterilization
Supports EtO/Gamma requirements.
Case Study — Class II Device: Zero Deviations at Launch
Challenge: Tight validation timeline
Solution: Parallel IQ/OQ prep + risk-based sampling
Outcome: On-time approval, zero deviations, full traceability
Validation Ready
Supports DQ/IQ/OQ/PQ with complete traceability.
Clean Manufacturing
Materials and finishes aligned to biocompatibility needs.
Risk Managed
FMEA and change control integrated from day one.
FAQs
Do you work under ISO 13485?
Yes—our approach aligns to ISO 13485 and risk-based principles.
Can you support FDA submissions?
We provide the tooling/process documentation needed by your RA/QA team.
What about biocompatible materials?
We help select materials and finishes consistent with your biocompatibility plan.
Do you supply PPAP for medical?
Where required, we mirror similar documentation conventions for medical equivalents.
Ready to bring your product or process to life?
Let’s discuss your project today — from prototypes to production-scale automation.