Go to Client Portal

Staci L. DeMoss, BS

Principal Validation Scientist

Reserve your Consultation with our Experts

Contact Us

Staci has worked in both quality and sterility assurance roles, supporting medical device manufacturing, before joining NAMSA as a Validation Scientist. Since joining NAMSA in 2008, her primary focus has been assisting medical device manufacturers in the creation and validation of reprocessing instructions for reusable medical devices.


  • Preparing technical documentation for reusable and single-use medical device process validations and managing validation activities, including laboratory instruction, scheduling and budgeting
  • Cleaning validations (manual and automated)
  • Disinfection validations (high-, intermediate- and low-level)
  • Sterilization (chemical, hydrogen peroxide, steam, ethylene oxide [EO], gamma and e-beam)
  • Residual cleaning and disinfecting agent testing
  • Preparing Instructions for Use (IFUs) outlining device reprocessing methods with consideration of user needs and practices
  • Preparing technical documentation for the grouping of medical devices into product families and selecting master product(s) for use in reprocessing validations
  • Preparing technical documentation providing product and/or process adoption rationale for new or modified medical devices
  • Preparing technical documentation, including feasibility test protocols, supporting the selection of medical device design features, to help ensure the final product design facilitates effective processing
  • Supporting efforts for EU Medical Device Regulation (MDR) compliance for the reprocessing of medical devices
  • Expertise in the U.S. Food and Drug Administration (FDA) Guidance Document “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling”
  • Providing training on medical device reprocessing requirements for the FDA
  • Member of the Association for the Advancement of Medical Instrumentation (AAMI)


  • Re-validated the IFU for a large medical device manufacturer’s product lines in order to comply with EU MDR
  • Created and validated IFUs for a multifaceted medical device system including multiple processes (i.e., cleaning, disinfection, EO hospital sterilization and steam sterilization) and multiple component types (i.e., critical, semi-critical and non-critical)
  • Created technical documentation for the grouping of multiple non-critical medical devices resulting in the reduction of cleaning and disinfection validations required for 510(k) submission