NOVO provides pilot manufacturing services to complement and augment our product development services. We maintain a controlled build area, operating under our ISO 13485/9001:2016 certification, for producing limited pre-production runs. These pre-production prototypes may be used for any purpose other than sale to end-users, including preclinical or clinical trials, beta testing, expanded market testing, compliance testing, or regulatory testing. Build documentation is generated according to the intended use of the devices (see below).

Our on-site pilot manufacturing services are advantageous to both startup and established clients: a pilot line operating under production-like controls, but in proximity to the R&D group, allows for rapid resolution of any issues discovered during assembly. Stable, repeatable, documented assembly and quality control processes can be developed. Quotes from prospective contract manufacturers will be more accurate, and opportunities for future cost reduction can be identified, among other benefits.

See how our pilot manufacturing services benefited a medical device product development effort.

Typical Pilot Manufacturing Documentation and Activities

  • Design master records (DMRs)
    • BOM
    • Component and assembly models and drawings
    • Device specifications
    • Packaging and labeling specifications
    • Software specifications, binaries, configuration files
    • Manufacturing process instructions (MPIs, WIs, SOPs)
    • Tool and equipment specifications
    • IQ, OQ, PQ
    • Gage R&R
    • Calibration requirements
    • Maintenance requirements
    • Tool and equipment specifications
  • Device history record (DHR)
    • Lot history records (LHRs)
    • Lot inspection reports
    • First article inspection records (FAIRs)
  • General
    • Material traceability
    • Training records