In recent years, there have been many reported incidents of patient infection as a result of reusable medical devices that have been inadequately cleaned and reprocessed. Firms are subject to quality system regulation even if some cleaning validations of reprocessing reusable medical devices may be exempt from 510(k) premarket notification requirements.
In this session, expert speaker John E. Lincoln will discuss FDA expectations regarding reusable medical device design considerations, cleaning validation methods and labeling instructions for reprocessing reusable medical devices in compliance with FDA’s current policy. In particular, he will discuss what firms should consider when developing cleaning validations including cleaning instructions for reprocessing reusable medical devices.
Additionally, John will guide you through FDA’s current policy and regulatory requirements on cleaning validation for reprocessing reusable medical devices including labeling instructions contained in 510(k) or PMA. This session will help you be in alignment with the FDA’s current policy and will provide great opportunities to learn about regulatory requirements for mobile medical applications.
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Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
John E. Lincoln is the Principal of J. E. Lincoln and Associates LLC, a consulting company; with over 35 years of experience in U.S. FDA-regulated industries, 21 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation...
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