Quality and Compliance

Industry leading in-house metrology and testing to ISO standards

Quality is built into everything we do: our engineering supports it, our employees uphold it and our machines measure and test it.

Our commitment to quality includes real-time statistical process control, as well as lean manufacturing initiatives to streamline our supply chain, including dock-to-stock and Kanban consignment.

We also run a fully equipped metallurgy and metrology (M&M) lab with world-class gauges, fixtures and machines, including contact and optical coordinate measuring machines, scanning electron microscopes, energy dispersive spectroscopy (EDS) systems and laser micrometers. As our innovation engine, this lab enables us to perform in-house tensile, electromechanical and corrosion tests, ensuring our medical products meet the strictest quality standards.

We continually review our design, manufacturing and testing processes, validating them against best practices and according to ISO standards:

ISO 9001:2015 certified

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AS9100D
(Based on and including ISO 9001:2015)

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EN ISO 13485:2016

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Capabilities

  • In-house metrology
  • Verification and validation
  • Tensile, electromechanical and corrosion tests
  • Lean manufacturing processes—Process Maps, Poka-Yoke, Kaizen and Recordkeeping

Equipment

  • Fowler-Sylvac Scan F60T Optical Scanner
  • Hexagon Global Performance 575 coordinate measuring machine (CMM)
  • Renishaw PH10M PLUS motorized indexing heads
  • Renishaw TP200 probe
  • Hexagon PC-DMIS metrology software
  • Keyence IM-6145 Image Dimension Measurement System
  • OGP SmartScope® Flash™ 200 automatic measurement systems, with ZONE3® Metrology Software
  • Four Starrett HDV300 Horizontal Digital Video Systems
  • Werth TomoScope XS 160 Computed Tomography (CT) Scanner
  • Zeiss MICURA 575 (VAST XT Gold probe) CMM

Contact us to get a quote.

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