Certification | ISO 13485:2016 |
Audit Performance | 2024 and 2025 audits passed with zero nonconformances |
Our Approach | Solve upstream issues, adjust in real time, and deliver with confidence |
Why It Matters | Globally recognized framework for consistent, compliant production |
Framework | Current Good Manufacturing Practices (cGMP) |
Supplier Quality Rate | 99%—driven by strong vendor qualification and inspection |
Continuous Improvement | Lean teams, operator input, process validation |
Automation & Tools | CAD/CAM, robotics, SPC |
Traceability | ERP-managed lot control, tooling, and parameter tracking |
Why It Matters | Fewer defects, better audits, and long-term manufacturing reliability |
UDI | Applied where applicable for regulatory tracking |
ERP Integration | Serialized lot-level control for every batch |
Electronic QMS | Centralized, validated, and always audit-ready |
GDP Compliance | Ensures consistency, accuracy, and traceable records |
Why It Matters | Reliable part history, faster audits, and confident decision-making—for us and our partners |
IQ | Verifies installation against design and manufacturer specs |
OQ | Tests performance under low, nominal, and high conditions |
PQ | Demonstrates consistent output under real production use |
Data Integrity | All steps analyzed, reported, and signed off |
Why It Matters | Validated, low-risk processes that meet specifications and build confidence across project teams |
We help OEMs bring complex molded components to life—with the care, speed, and flexibility they depend on.
No two projects are the same, and that’s where we thrive. With flexible thinking, smart design, and global execution, we find the best way forward.
About our services
We deliver injection molding, injection blow molding, cleanroom assembly, and automation—built to support complex, high-volume medical manufacturing.
What we do