Go to Client Portal

Ed Arscott, BS

Principal Strategy Consultant, Microbiology

Reserve your Consultation with our Experts

Contact Us

Ed first joined NAMSA in 1987. Since that time, Mr. Arscott progressed to the role of Manager of Microbiology and In vitro Toxilogy before leaving to take a role with Depuy/J&J, where he stayed for 14 years. Ed then returned to NAMSA in 2013—first, in a Validation Group technical position before taking on his current role as a Principal Strategy Consultant. In this role, he consults in medical devices with experience in all terminal sterilization methods (traditional and novel), Biological Indicator (BI) development, packaging shelf-life studies, medical device reprocessing validations, environmental monitoring and cleanroom qualifications. 


  • Technical Advisor for a worldwide orthopedic company, including projects that are focused on biocompatibility, aseptic processing, ethylene oxide, gamma, electron beam, gas plasma and laboratory operations
  • Implementation of GLP and GMP practices for all phases of microbiological testing, BI production and In Vitro biocompatibility testing
  • Consultation on ethylene oxide, gamma and e-beam sterilization validations and disinfection efficacy, steam sterilization, packaging shelf-life studies and cleaning efficacy validation studies for reusable devices
  • Subject matter expert for auditing of external contract laboratories and sterilization vendors
  • Regular interactions, on multiple levels, with regulatory agency submissions and regulatory compliance audits
  • Active participant in many AAMI Sterilization Standards Committees since 1992


  • Coordinated the design, layout, equipment procurement and validation of a new ISO Class 7 cleanroom, allowing for regulatory inspection and approval
  • Conducted an epidemiological risk assessment for a reusable oral medical device to justify the appropriate cleaning and disinfection levels in a regulatory submission
  • Managed multiple, full EO sterilization validation studies, which were being conducted at the same sterilizer for three separate clients during the same period


  • Validating Reusable Medical Devices: An Overview. Susanne Anderson, Ed Arscott, John Broad, and Dave Parente. Medical Device & Diagnostic Industry, January 1996.
  • Validating Radiation Sterilization in a Global Marketplace. Ed Arscott, Susanne Anderson, John J Broad and Dave Parente. Medical Device & Diagnostic Industry February 1999.
  • A Practical Guide to ISO 10993-5: Cytotoxicity. Richard F. Wallin, Ph.D, Edward F Arscott. MDDI. 1998;20:96–8