As regulatory expectations evolve, manufacturers face mounting pressure to prove reusable medical devices can be consistently cleaned, disinfected, and sterilized without compromising safety or performance. Effective reprocessing goes beyond individual test by addressing complex standards, validation expectations, microbiology, and risk management to maintain lifecycle safety and effectiveness.
We’ll explore critical reprocessing validation elements and complementary microbiology services supporting regulatory success, device quality, and patient safety.
During this webinar, we will discuss:
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Lori Graybill Technical Development Manager Eurofins Medical Device Services |
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As a Technical Development Manager at Eurofins Medical Device Services, Ms. Graybill is responsible for leading the medical device reprocessing department, including but not limited to cleaning validations, disinfection validations, sterilization validations, and overseeing testing in support of sub-visible particulate testing and various antimicrobial tests.
Ms. Graybill has over 20 years of experience spanning both medical device and pharmaceutical industries, respectively, with a strong background in controlled manufacturing environments and routine microbiological testing for water systems, data analysis, and investigations.
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Katharine Winpenny Principal II Scientist Eurofins Medical Device Services |
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As Principal II Scientist, Katharine "Kathy" Winpenny serves as Eurofins Medical Device Services’ Microbiology subject matter expert for sterility, endotoxin, bioburden, antimicrobial, particulate, and reprocessing testing. She is responsible for the preparation and review of technical documentation, including protocols, procedures, and final project reports.
An active member of AAMI, the Association for the Advancement of Medical Instrumentation, she has more than 30 years of microbiology experience spanning the medical device, pharmaceutical, consumer products, and clinical microbiology industries, with extensive expertise in microbiological method development, validation, and regulatory-compliant testing programs.
Kathy holds a Bachelor of Science in Laboratory Science from Loyola University Maryland.
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As regulatory expectations evolve, manufacturers face mounting pressure to prove reusable medical devices can be consistently cleaned, disinfected, and sterilized without compromising safety or performance. Effective reprocessing goes beyond individual test by addressing complex standards, validation expectations, microbiology, and risk management to maintain lifecycle safety and effectiveness.
We’ll explore critical reprocessing validation elements and complementary microbiology services supporting regulatory success, device quality, and patient safety.
During this webinar, you will learn:
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Lori Graybill Technical Development Manager Eurofins Medical Device Services |
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Katharine Winpenny Principal II Scientist Eurofins Medical Device Services |