Manufacturing electro-mechanical devices can get complex, but when the device in question is a class 2B medical device performing potentially life-critical functions there is no room for error. Processes are developed, certified, and documented to ensure 100% of the products leaving the door are fit to perform their intended function.
To achieve compliance with the Medical Device Directive (MDD), ISO 13485, and the standards set by the European Commission, documentation of the manufacturing process is a key area subject to rigorous evaluation. Whilst working at Intersurgical I was tasked with creating a number of these documents, with a sizeable portion of that work going into producing a set of comprehensive Assembly Instructions for a ‘Medical Gas Blender’.
The device features a complex set of operations, overlapping significantly with those of a Ventilator. The device comes in at a much cheaper price point and finds itself in a hospital’s arsenal as a tool that reduces demand on their limited number of Ventilators, freeing them up for the most life-critical patients.
During the production of the assembly instructions, I was able to thoroughly assess the Gas Blender’s manufacturability, highlighting several issues and implementing a variety of design changes with a ‘design for assembly’ focus. As this document neared completion I liaised with the 3rd party company contracted to assemble the device to gain their insight and optimise the process for their facilities and technician capabilities, and attended their site to aid in the establishment of specialised assembly cells and provide operative training.
The document produced detailed every step of the meticulous assembly process, including traceability steps, tracking of component batch/serial numbers, Factory Acceptance Testing of completed units, and any troubleshooting steps for problematic devices.
