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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
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
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
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
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
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
Packaging & Sterilization
|
Testing
Coming Clean: Developing Standards for Cleaning Reusable Devices and Instruments
...
Dawn A. Lissy, President & Founder, Empirical
07.26.18
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
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
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
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
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
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
A Look into ISO 14971: Risk Management and Quality System Integration
...
Emily Ysaguirre, VERSE Solutions
07.26.17
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
R&D & Design
|
Testing
The Human Factor
...
Steve Maylish and Dave Hines, Fusion Biotec
05.01.17
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
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
Cardiovascular
|
Contract Manufacturing
|
Materials
|
Testing
Sterilization Innovations Lead to New Guidance Document
...
James A. Dunning, QPC Services
05.06.16
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
R&D & Design
|
Testing
FDA Encourages Human Factors Testing
Agency released two drafts and one final document emphasizing importance.
AAMI
02.18.16
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
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
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
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
AAMI 2015 Conference & Expo
...
03.11.15
AAMI Healthcare Technology Management Week
...
10.27.14
AAMI Sterilization Standards Week
...
10.27.14
AAMI Quality System Requirements and Industry Practice
...
10.27.14
AAMI Standards Week
...
10.27.14
AAMI 2014 Conference & Expo
...
01.10.14
Challenge 2014 - AAMI/FDA Forum on Standards, Synthesis, Solutions
...
01.10.14
Contract Manufacturing
|
R&D & Design
|
Software & IT
AAMI Develops Benchmarking Tool for Device Makers
...
11.13.13
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
Contract Manufacturing
Industry Associations
...
09.16.10
Trending
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Portable, Home-Use Device Quickly Measures Inflammation Levels
Medtech Matters: Talking Robotic Surgery With Zimmer Biomet
Breaking News
Optimize EP Launches CaRM Cardiac Device Data Management Platform
U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030
FDA Clears Canon Medical's Compressed SPEEDER for 3D Exams on 1.5T MR
Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation
Moon Surgical Expands Leadership Team
View Breaking News >
CURRENT ISSUE
November/December 2020
Pharmaceutical Focus: A Look at Combination Products
The Printed World: Additive Manufacturing in Medtech
The Lost Year: 2020 Year in Review
View More >