Profile: Hiemstra Product Development is an innovative product design and development company serving the life sciences industry. We serve medical technology companies from early-stage ideation to final assembly, or any step along the way. We have introduced our hiQual quality management system (QMS), which streamlines medical device design and development, from feasibility through manufacturing. This new, electronic QMS is completely digital, ISO 13485:2003 and QSR compliant. We have a full suite of hiQual software modules, which ensure that all of our creative and innovative medical designs meet strict design control standards during every step of the process by doing it right the first time. Its benefits are solid regulatory submission data, portability for manufacturing, identification of risk earlier in the venture and elimination of backfilling of documentation for quality, regulatory or manufacturing requirements.