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Tony Piotrkowski

Director of Regulatory Affairs
STERIS Corporation, Ohio, United States

Tony is Director of Regulatory Affairs at STERIS Corporation in Mentor where his team is responsible for ensuring compliance with US regulations throughout the product lifecycle. On the premarket side he and his team are involved in all new product development projects and submit about 20 premarket submissions each year. Post-market, his team oversees design change orders, risk management reviews and assists with inspections readiness and adverse event investigations. Tony is also involved in standards development both domestically: through AAMI where he chairs sterilization standards Working Group 6 and serves on various Sterilization and Quality Systems standards Working Groups and internationally where he serves on several ISO Working Groups. He has an MS in Molecular Biology and holds a US RAC.

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