• Pre-production support, pFMEA, control plans, manufacturing process instructions, etc.
  • Quality manuals
  • Medical market process verification
  • IQ, OQ and PQ for processes and equipment
  • pFMEA development
  • FDA Title 21 Part 820 FDA compliance
  • Content for design history files and device master records – materials and process
  • Live large screen SPC and CpK metrics in manufacturing areas
  • Certified operator training with records
  • S 2020 ESD compliance

Quality is evident throughout the supply chain

  • Automated MRP and production control system
  • Consigned and turnkey materials
  • Full traceability, build records and C of C’s
  • On demand inventory and cycle counts
  • AVL adherence
  • Vendor audits and qualifications
  • IQC of all materials
  • Alarm monitored freezers
  • Nitrogen storage cabinets
  • Expiration date tracking

Quality is assured by a certified supplier