The Biotronics DB1portable embryo freezer provided controlled freezing of both human or animal embryos or sperm (www.biotronics.net) . The machine uses liquid nitrogen as its cooling source and a controlled heater plate to maintain user programmed heating/freezing cycles. The system uses an 80C552 based processor with graphics screen, heater drivers, PRT temperature detectors, PC upload and download of configuration and calibration data, printer outputs and service access for field maintenance or remote diagnostics.

E2L were initially approached to provide third party software validation in order to achieve FDA approval in the United States. This required a full software audit and risk assessment report. The original code was written in FORTH, and fortunately E2L have high experience in this specialist area.

The relationship then expanded with Biotronics since the original manufacturing data had been lost and a full drawing process needed recovering. Much of the ongoing work involved reverse engineering the product in order to regenerate the necessary build information. This work covered electronic and mechanical skills, as well as identifying manufacturing sub-contractors and managing production runs.

Certain aspects of the design had to be changed, in particular the battery management system.

The project is an example of ‘legacy system support’ which occurs when either documentation is lost, damaged, or sabotaged. More commonly it arises out of poor initial documentation and management systems, and an over reliance on local knowledge, only to find incomplete data once a key member of staff has left the company.