Our partners' commitment to compliance.

  •  ISO 14971:2007; EN ISO 14971:2012
  • ISO 13485:2003 Certified Quality Management Systems
  • ISO 11607
  • ISO 9001
  • ISO 14001
  • FDA registered and audited facilities to include the California Food & Drug Branch
  • Directive MDD 93/42/EEC
  • CE Marked Products
  • Japan’s MHLW Ministerial Ordinance No. 169  

QUALITY CONTROL

  • Quality control, cost reduction, and precision manufacturing. 
  • ISO Class 7, 8, 9 controlled environments
  • cGMP (current Good manufacturing procedures)
  • 5s Methodology
  • Controlled fixtures and gauges; NIST and for our defense customers, MIL SPEC traceable calibrated instruments
  • ASTM standards
  • Kanban inventory systems packaging
  • Just in time shipments for zero inventory costs
  • No cost tooling for qualified orders
  • For the defense industry, ITAR registration

PARTNER CONTRIBUTIONS

Employee and environmental health is key. 

  • Workforce wellness and social responsibility programs

  • Wind energy powered plants
  • Wetland protection
  • Waste reduction management and education