A Turnkey Contract Manufacturing Solution

Chelle Medical’s contract assembly services include:

  • Light electromechanical/mechanical assembly
  • Silicon product assembly
  • Functional testing
  • Supply chain management/parts procurement
  • Logistics management
  • Refurbishment/Remanufacturing
  • Packaging

Our strong focus on regulatory compliance includes:

  • EN ISO 13485:2016 registered
  • Compliant with US FDA 21 CFR Part 820
  • Compliant with Japan MHLW Ordinance No 169
  • Certified by SGS (Singapore)

Production infrastructure includes:

  • Class 8 cleanrooms
  • ESD protected areas (where required)
  • Laser marking capabilities for traceability