Metrology & Validation – Tool & Gauge

Key Metrology Applications Across the Moulding Process

Mould Validation

Verify mould cavity dimensions with Coordinate Measuring Machines (CMMs), achieving critical tolerances.

First Article Inspection (FAI)

Conduct comprehensive part validation before mass production. Advanced vision systems ensure parts like medical device housings meet strict ISO 13485 standards.

In-Process Quality Control

Monitor parts dynamically during production runs using vision systems. Statistical Process Control (SPC) proactively identifies trends.

Rigorous Validation Processes

Validation is a critical stage in any medical device manufacturing process, and we excel in this area. We meticulously carry out validation on all new tools and components, guaranteeing they meet the highest standards of quality, functionality, and safety before they reach our clients.

Our robust validation protocols minimize risks and ensure compliance with all regulatory requirements, providing peace of mind for our partners.

Our Comprehensive Validation Process

Installation Qualification (IQ)
We verify that all equipment, is correctly installed according to specifications.

Operational
We confirm equipment operates under defined conditions. Our process window studies using DoE achieve CpK > 1.33, ensuring 99.99% consistency on critical dimensions for our components.

Performance Qualification (PQ
We guarantee consistent product quality in routine production, demonstrated by 3-lot runs with 100% first-pass yield and zero critical defects. We implement SPC for critical dimensions on our components.

Documentation & Traceability
Our process includes full validation reports and lot traceability for all materials. Digital records are maintained ensuring complete regulatory compliance.

Cleanroom Manufacturing
Our ISO Class 8 (100,000) certified facilities provide a controlled environment for molding and assembly, critical for high-quality
medical device components.