Traceability of the components is a critical part of the quality assurance processes required to gain regulatory approvals for medical devices.
For most medical devices, implementing traceability at the batch level is sufficient. However, for applications where correct operation of the device is critical to sustaining or supporting a patient’s life (Class III), product manufacturers will ask for traceability at the device level. Because Class III devices are relatively rare and usually low volume, electronics manufacturers typically use a manual system of some sort to record where every component goes.
However, when Circuitwise was awarded the contract for PCB Assembly of Grey Innovation’s NOTUS Viviere emergency ventilator, the order was for over 2000 boards. Circuitwise decided to take the opportunity to implement an automatic system, leveraging the power of its Cluso inventory management system.
With the Cluso system, every part (or reel or parts) is logged as it moves through the production process, starting with the application of a serial number to both PCB bare boards and to the reels of components (or other packaging formats).
With the ventilator project, we decided to automate the recording reel changes during a production run, allowing us to more easily trace which components from which reel went onto which boards.
An example matrix is shown below from the Cluso system. On the left axis are the serial numbers of PCBs. On the top axis are the identification numbers for each component of the PCBA design. Populating the centre are all the serial numbers for each component or reel of components.
The red box highlights a change of reel (and hence a new serial number). For the ventilator project, there were 75600 unique components tracked across 2100 boards.
This information is exported and sent to the product owner to form part of their Device History Record, which is required for regulatory approval.
See more information on our Traceability Systems or contact us to understand how we can help you meet your regulatory obligations in your next medical device product development.