NPI Support

Medimor's NPI team is highly experienced in the medical device industry and provides support for start-ups and more mature companies, from the stages of concept and prototype through to production and final end-customer delivery. Our services include:

  • Establishment of production processes and infrastructure
  • Testing and validation
  • Development of production line to a demonstrated confidence level (level of reliability)
  • Management of Bill of Materials (BOM) and configuration control
  • Engineering  design of processes and tools utilizing such software as: SolidWorks, PRO E, Cimatron, Altium Designer, LabView, StatGraphics, ViewMate Gerber Editor & Optimizer
  • Obtaining cost-effective supplier bids
  • Production Readiness Review (PRR)
  • Design of Experiments (DOE)
  • Lab testing (for internal reliability purposes)
  • All processes and tools are subject to IQ/OQ (Installation and Operations Qualification)
  • Performance Qualification (PQ) – performed during production phase
  • Continuous improvement throughout the production process
  • All tools are periodically calibrated and undergo preventive maintenance according to medical guidelines and regulations