One of our first projects was in the area of systems engineering for a digital pathology medical device. The work that we performed was to ensure that the entire design was traceable to a set of documented requirements. This is the case, for example, for the FDA Quality System Regulation 21 CFR Part 820. Most medical device manufacturers worldwide need to adhere to this regulation, as it is mandatory for devices manufactured or sold in the United States. IBM DOORS was used in this project to allow tracking of these requirements in preparation for an FDA audit of our quality processes. We provided leadership and implementation in the areas of

  • Requirements analysis and system engineering for the design of digital pathology systems at Omnyx, LLC.
  • Identify and document requirements using IBM DOORS product in compliance with FDA quality guidelines for the development of medical devices.