About Us
Experience
Experience
Experience
EDan-SA LLC Consulting was founded by Elaine M. Daniell, who brings over 30 years of experience in the areas of medical device and biologics sterilization, environmental microbiological control and laboratory testing associated with sterilization processes and monitoring.
Approach
Experience
Experience
Our goal is to provide innovative solutions and technical expertise to ensure compliance to sterilization regulatory standards while providing an optimized and most cost effective approach to your medical product sterility assurance program. EDan-SA will provide hands-on support to identify gaps and opportunities, provide education and pa
Our goal is to provide innovative solutions and technical expertise to ensure compliance to sterilization regulatory standards while providing an optimized and most cost effective approach to your medical product sterility assurance program. EDan-SA will provide hands-on support to identify gaps and opportunities, provide education and partner with your business to mitigate issues and drive results for success.
Profile
Experience
Profile
EDan-SA LLC is a corporate member of the Association for the Advancement of Medical Instrumentation (AAMI) and actively participates in standards development as part the International Standards Organization (ISO). Elaine M. Daniell is the current co-chair of the WG2 Radiation for AAMI and ISO US delegate. Elaine has certification by ACI
EDan-SA LLC is a corporate member of the Association for the Advancement of Medical Instrumentation (AAMI) and actively participates in standards development as part the International Standards Organization (ISO). Elaine M. Daniell is the current co-chair of the WG2 Radiation for AAMI and ISO US delegate. Elaine has certification by ACI as Certified Sterilization Specialist in Ethylene Oxide and Radiation Sterilization and by ASQ as a Certified Quality Auditor.