Shelley has been in the MedTech industry for 25 years, with 23 years focused on medical devices specifically in cardiovascular, orthopedic and dental.

Shelley joined NAMSA in 2015 following a career in the medical device testing industry including roles in Laboratory Operations and Quality Assurance. She has worked in the laboratory performing bioburden and sterility testing and has also managed staff performing microbiology testing (i.e. microbial enumeration, sterility, antimicrobial testing). As part of her management role, she performed investigations, corrective actions and improvement action plans for microbiology labs. In her role at NAMSA, she assists medical device manufacturers in the validation of radiation sterilization and ethylene oxide sterilization processes for single-use medical devices, packaging and shelf-life validations, and the development and validation of instructions for use for reusable medical devices.

Shelley has assisted clients with their submissions to the Food and Drug Administration (FDA) and other Notified Bodies, such as TUV. She has assisted clients with requirements for reusable device validations for the European Union Medical Device Regulation (EU MDR).

Shelley has a Bachelor of Science Degree in Biology. She is a member of the Association for the Advancement of Medical Instrumentation (AAMI) Sterilization Standards Committee and is a voting member on several sterilization standards working groups.

CORE COMPETENCIES

• Providing technical support in the design and development of:
  • Radiation and ethylene oxide sterilization validations of single-use medical devices
  • Cleaning, disinfection and sterilization validations of reusable medical devices
  • Packaging and shelf-life validations
• Providing technical support for the adoption of new products into existing:
  • Radiation and ethylene oxide sterilization cycles
  • Reusable device validations
• Preparing Instructions for Use (IFUs) outlining device reprocessing methods
• Providing training on:
  • Medical device reprocessing requirements for the FDA
  • Requirements for radiation sterilization validations

RECENT PROJECTS

• Worked with a device manufacturer to answer U.S. Food and Drug Administration (FDA) questions regarding reprocessing, resulting in successful validation of updated manual cleaning and disinfection processes (FDA approval)
• 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
• Validated a manufacturer’s new device system which included multiple processes (radiation, cleaning, steam sterilization) with multi-component types (critical and non-critical)