• 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