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
Seeking Sterilization Solutions: A Look at Ethylene Oxide
An examination of the recent controversy surrounding ethylene oxide and its impact on supply risk as well as the search for alternatives.Paul Boentges and Sam Ramnarine, Jabil Healthcare 03.04.20
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Testing
Testing in Flux: Changing Protocols for a Transformative Industry
As regulations and requirements around the world change, so too do the testing protocols for medical devices, sending OEMs to consult expert partners.Mark Crawford, Contributing Writer 03.04.20
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Class Ir Device Manufacturers Must Keep Their Feet on the Gas
The recent deadline extension for Class I reusable devices to comply with MDR is a relief, but these next four years will go by fast.Dan Fowler, Principal Scientist, WuXi Medical Device Testing 03.04.20
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Electronics | Software & IT | Testing
EMC and Wireless Compliance of Active Implantable Medical Devices
It is imperative to ensure AIMDs' safety and performance regarding EMC and wireless coexistence.Online Exclusives Minal Shah, Sr. Project Engineer, Intertek 10.29.18
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Packaging & Sterilization | Surgical
Olympus Introduces OER-Mini Endoscope Reprocessor for ENT
Tabletop endoscope reprocessor features 16-minute reprocessing time; helps reduce the risk of human errors and mishandling.Olympus 10.05.18
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Packaging & Sterilization | Testing
Coming Clean: Developing Standards for Cleaning Reusable Devices and Instruments
...Dawn A. Lissy, President & Founder, Empirical 07.26.18
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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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Software & IT
GE Healthcare Launches VR Training for Healthcare Technology Management Professionals
GE Healthcare trains more than 8,000 HTM professionals each year.GE Healthcare 06.01.18
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Packaging & Sterilization
How Pre-Validated Packaging Complies with ISO Standards
An examination of considerations device manufacturers need to keep in mind when using pre-validated packaging.Online Exclusives Jeff Barrett, President and CEO, J-Pac Medical 03.20.18
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DuPont Launches New DuPont Tyvek 40L in China with Plans for Global Availability in 2018
DuPont expands family of Tyvek styles for medical packaging to meet marketplace needs.DuPont 10.05.17
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Digital Health | R&D & Design | Software & IT
5 Medtech Trends Shaping 2017: Cybersecurity
Cybersecurity risks will continue to threaten device innovation.Online Exclusives Alex Butler, Manager, Medical Device Solutions, MasterControl 08.31.17
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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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A Look into ISO 14971: Risk Management and Quality System Integration
...Emily Ysaguirre, VERSE Solutions 07.26.17
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Cardiovascular | Digital Health
Cardiologs ECG Analysis Platform Receives FDA Clearance
Platform bills itself as is the world’s most advanced cloud-based and artificial intelligence-powered ECG analysis solution.Business Wire 07.20.17
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R&D & Design | Testing
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Contract Manufacturing | R&D & Design | Software & IT | Testing
A Holistic Approach to Software Outsourcing
...Steve Maylish and Frances Cohen, Fusion Biotec and Promenade Software Inc. 06.09.16
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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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Cardiovascular | Contract Manufacturing | Materials | Testing
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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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R&D & Design | Testing
FDA Encourages Human Factors Testing
Agency released two drafts and one final document emphasizing importance.AAMI 02.18.16
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R&D & Design | Testing
FDA Releases Recommendations on Design, Labeling of Interoperable Devices
Achieving widespread interoperability between medical devices and health IT systems has been a challenge.AAMI 02.01.16
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FDA Proposes Early Warning System for Potential Device Safety Issues
New solution would alert public to potential issues prior to investigation.AAMI 01.08.16
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FDA Narrows ‘Convenience Kit’ Definition for UDI Labeling
Update creates stricter interpretation of the term for UDI labeling and data submission requirements.AAMI 01.06.16
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Software & IT
FDA Announces Its New Year’s Resolutions for 2016
List includes 510(k) modifications and a UDI convenience kit.AAMI 01.04.16
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Contract Manufacturing | R&D & Design | Software & IT
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Contract Manufacturing | R&D & Design | Software & IT
AAMI Develops Benchmarking Tool for Device Makers
Platform designed to help companies measure quality management systems.10.23.13
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Contract Manufacturing
