Search Results for 'aami'
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Packaging & Sterilization
FDA Clears 15-Minute Hydrogen Peroxide Sterilization System
Advanced Sterilization Products claims process is 38 percent faster than competitors.Business Wire 03.09.20
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Packaging & Sterilization | Testing
Five Aspects of the ISO 11737-1:2018 Updates You Need to Know
What medical device manufacturers need to know about the recent changes to the ISO bioburden standard.Martell Winters, Director of Scientific Competency, and Wendy Wangsgard, Ph.D., Senior Scientist—Nelson Laboratories 07.23.18
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Digital Health | Electronics | Software & IT | Testing
Coexistence Testing for Wireless Medical Devices: A Guide to Ensuring Reliable Systems
With mobile medtech in healthcare facilities and the home, OEMs must ensure interference is not a cause for concern.Online Exclusives Ashton Hainge, Consultant, Intertek 08.02.17
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Stakeholders Anticipate FDA Action on Third-Party Repairs
Original equipment manufacturers (OEMs) often are uneasy about the quality of repairs made in the field.AAMI 06.06.16
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Contract Manufacturing | R&D & Design | Testing
When Do I Really Need to Perform an EO Requalification?
An examination of the changes in ANSI/AAMI/ISO 11135:2014.Dan Floyd and Paul Littley , Nelson Laboratories Inc. 04.06.16
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Contract Manufacturing | R&D & Design | Software & IT
AAMI Develops Benchmarking Tool for Device Makers
AAMI has developed a new benchmarking tool to help medical device designers and manufacturers determine how their quality management systems (QMS) compare with that of their peer companies, just as the U.S. Food and Drug Administration (FDA) increase…11.13.13
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R&D & Design | Testing
Two Organizations Join to Set Standards for Medical Device Interoperability
Officials claim the space of interoperability needs to be developed.09.17.12
