Medical Device Injector

Our Client was developing a compact, portable, and battery operated anaesthetic injector for post-operative pain management, and engaged Boost Design to develop all of the electronics, firmware, and clinician software for the device.

Boost Design conducted the following activities:

  • Review of product requirements and design of product architecture
  • R&D into options for device minaturisation
  • Development of all electronic hardware
  • Development of all product firmware
  • Development of Clinician Software, suitable for configuring dosage levels, unique to each patient/device
  • Development to medical device standards in accordance with ISO13485 quality management system, ISO14971 Risk Management, IEC62304 Medical Device Software Development
  • Development in consideration of IEC60601 electrical safety and EMC requirements
  • Conduct verification testing on the electronic, firmware and software components of the device
  • Supply appropriate regulatory documentation relating to the electronics, firmware and software design, including design descriptions, system requirements, risk analysis, traceability matrix, and verification protocols and reports
  • Provide design files to the selected manufacture in preparation for clinical trials