BionX Medical Technologies meets time-to-market, compliance, and efficiency goals for the prosthesis. The emPOWER Ankle is a complex active prosthetic foot and ankle solution that replaces muscle and tendon function, supporting users with additional energy while they walk.
Because of the devices’ complexity, even slight changes to the product or documentation result in large amounts of paper documentation, which must be manually compiled and routed for review and approval.
With a major re-design project on the horizon, BionX Medical Technologies Inc.’s engineers began evaluation solutions to replace the paper-based document control and change the control system that was becoming unmanageable. Company officials wanted an electronic product lifecycle management (PLM) system that would efficiently manage a multi-level product structure/bill of material (BOM) and engineering change orders, with the ability to expand into other electronic records management such as training records, corrective and preventive actions (CAPA)/quality issues, and supplier management. The system had to meet the FDA 21 CFR Part 11 compliance requirements for electronic records and electronic signatures.
Read more >PLM streamlines prosthetic design, redesign