Organization: GN Hearing
Business: Development and sales of hearing instruments, accessories and software solutions (incl. apps) to improve the quality of life for the hearing impaired. Global technology leader in segment, with partnerships with Apple, Google, and Cochlear.
Assignment completed: In preparation for an FDA inspection, ensure correctness and completeness of all GN Hearing Design Controls projects, completed the last 3 years. Project managing reviews, document updates, and SME preparation for inspection. Back office coordinator during FDA inspection. Project managing post inspection quality efforts.
Organization: Otometrics, a division of Natus
Business: Development and sales of medical devices within hearing and balance assessment. Global leader in segment.
Assignment completed: As part of Natus’ acquisition of Otometrics, and the corresponding need to integrate Otometrics processes and systems into Natus’ processes and system, Otometrics needed support for ensuring data validity of all historic Product Lifecycle Management data contained in the Oracle Agile system. Oracle Agile is an FDA CFR21 part 11 validated system for handling Product Lifecycle Management product data for medical devices. The goal was to ensure completeness of data transferred, as well as ensuring historical data remained available for Otometrics.