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Follow on Google News | Protocol Link Enhances Website Publication Series with New White Paper on Reprocessing SUDsThis press release provides information about Protocol Link's white paper that addresses the practical process of applying key elements of the FDA regulations governing systems for purposes of enhancing and ongoing compliance related to Single-Use De
The author addresses specific steps that manufacturers of Single-Use Devices (SUDs) must take to assure product safety, efficacy and customer satisfaction, by highlighting in detail, the minimum required elements of Quality System Regulation (21 CFR Part 820) and providing insight into the corollary responsibilities of SUD reprocessors. “From my experience, hospitals and companies that reprocess Single-Use Devices typically do not realize their product is classified as a medical device that falls under the purview of QSR regulations,” Mr. Cerny has more than 15 years of experience in the pharmaceutical, biotechnology and process filtration industries and has assisted Protocol Link clients with fulfilling their regulatory requirements. He holds an MBA in International Business from Roosevelt University Chicago and a Bachelor of Science in Chemical Engineering from Iowa State University. About Protocol Link With an established client base worldwide, Chicago-based Protocol Link, Inc., is a leading project management and consulting firm dedicated to providing comprehensive regulatory compliance, quality assurance, cGMP documentation, validation, and technology services to FDA-regulated life sciences companies worldwide. Founded in 1996, Protocol Link’s mission is to provide customer-focused services with ethical conduct, mutual trust, and personnel empowerment. Additional information can be obtained by visiting Protocol Link’s Web site at: www.protocollink.com. # # # Protocol Link, Inc. is a global project management firm organized to provide comprehensive consulting services for FDA-regulated companies, including regulatory compliance, validation, and quality assurance. End
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