Quality and Regulatory
Taking your design from art to part. Together we’ll create it and make it.
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01
Quality System Rental
01
Quality System Rental
Utilizing Quality Collaboration By Design (QCBD) as our Quality Management System (QMS) we provide an EN ISO 13485:2016 and FDA compliant system for rental for the manufacture of components, subassemblies, and finished assemblies
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Testing Services
02
Testing Services
**Biocompatibility Testing **Sterilization Validation Testing **Regulatory Filing Consulting **Maintenance of DHF/ Tech Files **CE Mark Maintenance **Market Surveillance
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Verification and Validation Testing
03
Verification and Validation Testing
**Radial Force Testing **Tensile Testing **Micro Device Tensile Testing **Bench Testing **Torque Testing **Feasibility Testing **Competitor Testing **Compatibility Testing **Burst Testing
More Info04
Regulatory Filing
04
Regulatory Filing
**Review and Compile Design Dossier / Technical File for CE/FDA **Facility Registration **Product Registration
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