Nicholas Werner

Biomedical Engineer / Scientific Reviewer – Office of Device Evaluation (ODE), Dental Devices Branch and General Hospital Devices Branch Biomedical Engineer / Analyst – Office of Surveillance and Biometrics (OSB), Product Evaluation Branch My work in the Office of Device evaluation required me to participate in the interpretation and review of scientific data to ensure the safety and effectiveness of medical devices. This position allowed me to use my own judgment to gather and assess pertinent data and make recommendations on medical device actions [e.g., 510(k), PMA, and IDE decisions]. Proper time management and the ability to communicate effectively with various industrial professionals were greatly utilized in this position. My work in the Office of Surveillance and Biometrics required me to utilize an internal Oracle-based program, the Manufacturer and User Facility Device Experience (MAUDE) Database, for the evaluation, analysis, and investigation of medical device problem reports. From these reports, it was my responsibility to detect short term device problems along with potential trends that had been occurring over a longer period of time. This position provided the responsibility to initiate investigations of medical devices that warranted such action. Leadership skills were also utilized in this position, as many investigative actions require a presentation with a thorough background and potential steps forward addressed. Composing Adverse Event Report Memos required a detailed knowledge of various types of devices and how their design and/or intended use could contribute to a reported event. This work also required me to discuss policies on reporting with industry and to provide additional information regarding medical device reporting regulations as necessary.