Manufacturing processes within the biomedical and in vitro diagnostic areas such as assembly, inspection, testing, receiving, fabrication, sterilization, packaging, and others all require a careful process development method.
Taking a project from concept to the manufacturing floor allows LRE Medical to provide for a carefully planned and thought out process enabling a smooth transition from engineering to manufacturing. LRE begins each development project with the eventual serial production process in mind.
LRE engineers develop the process sequence, labor requirements and operator work assignments in accordance with ISO 13485 / ISO 9001 and FDA to achieve an efficient and safe production operation. This is ensured through the following process development steps: