High Performance. High Quality.

Service Driven:

• Anticipate and support our customers’ needs through proactive communication and partnership.
• Build strong relationships internally and externally to strengthen customer satisfaction and trust.
• Deliver high quality products and services that consistently meet customer expectations and intended use requirements.

Creative:

• Encourage innovation through employee engagement, collaboration, and continuous improvement across our products, services, and processes.
• Strengthen the effectiveness of our quality management systems through problem solving, efficiency, and operational performance.

On Time:

• Commit to on-time delivery through disciplined processes and accountability.
• Strive to do things “right the first time” to minimize risk, waste, and disruption.

Responsive:

• React quickly and effectively to customer, business, and regulatory needs.
• Promote open communication, adaptability, and timely resolution of issues.
• Continuously assess and align with evolving regulatory and market requirements across the regions we serve.

Excellent Quality:

• Maintain the highest standards of quality, safety, and compliance with integrity in our people, products, processes, and partnerships.
• Uphold effective quality systems that support compliance, product safety, and operational excellence.
• Commit to continuous improvement and achievement of our quality objectives.

We have designed our quality management system (QMS) to implement effective risk assessment and risk management to ensure compliance with customer and regulatory requirements. This creates a solid foundation to provide our customers with a reliable supply of high-quality products and services.

We are:

• FDA registered
• We have an ISO 13485:2016 system certified by DNV
  View our certifications
• Certified ISO 7 and 8 Cleanrooms
• Committed, through our internal audit and management review processes, to compliance with all relevant regulatory and statutory requirements, including but not limited to ISO 13485:2016, 21 CFR 211, and 21 CFR 820
• CE mark certified and UDI compliant for specific products as per European Union requirements
• Utilizing robust verification and validation processes including DFM, DFA, dFMEA, pFMEA, IQ, OQ, and PQ

Our ongoing investment in best practices and tools for metrology and inspection mitigates risk and guarantees consistent part quality. We have a variety of measurement systems to visualize; measure; and analyze internal components, surfaces, and complex geometries. We can also measure chemical, physical, and material properties. Our capabilities include the following:

• Vision systems
• Single- and multi-sensor coordinate measurement machines (CMM)
• Computerized tomography (CT)
• Fourier-transform infrared spectroscopy (FTIR)
• Laser micrometers
• Force testing instrumentation
• Color spectrophotometry
• High-speed leak testing
• GR&R studies performed on all metrology equipment for critical dimensions
• Custom jig and fixture creation

To address custom applications, we can also develop specialized testing equipment and approaches that facilitate your medical innovation.