Testing
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Testing
Nelson Labs Expands Illinois Lab Operations and Testing Capabilities
New testing capabilities will be fully operational beginning May 1.Nelson Laboratories 04.23.18
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Testing
FDA's Expansion of 510(k) Program Seeks to End Predicate Testing for Some Devices
Voluntary, modern 510(k) pathway may enable moderate risk devices to more efficiently demonstrate safety and effectiveness.U.S. Food and Drug Administration 04.13.18
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Testing
The Value of (Outside) Evaluation: Outsourcing Testing Services
Testing service and equipment providers are challenged to stay abreast of regulatory guidelines.Sam Brusco, Associate Editor 03.15.18
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Testing
NAMSA Expands German Medical Device Testing Services
The world’s only Medical Research Organization launches new Analytical Services Laboratory in Obernburg, Germany.Business Wire 02.01.18
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R&D & Design | Testing
5 Questions from the Booth: NAMSA
A medical research organization provides product testing, clinical trial, and regulatory related services.MPO Staff 11.20.17
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3D/Additive Manufacturing | R&D & Design | Testing
J&J Unveils Center for Device Innovation at Texas Medical Center
R&D staff will work on select internal projects along with strategically aligned external ventures of JJMDC.Videos PR Newswire
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Packaging & Sterilization | Testing
Sterigenics International Changes Name to Sotera Health
Leverages the strength of Nelson Labs, Nordion, and Sterigenics to deliver on its mission of safeguarding global health.Sotera Health 11.08.17
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3D/Additive Manufacturing | Testing
The Final Four: My Top Headlines for 2017
In a year of political and social discord, international conflict, and natural disasters, the big news in the medical device industry really didn’t make headlines—even within our sector. But as 2017 comes to a close, I consider fee hikes,…Dawn A. Lissy, President & Founder, Empirical 11.07.17
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R&D & Design | Testing
Mike on Medtech: Pre-Sub with the FDA
Mike Drues and Sean Fenske discuss the benefits of the FDA's pre-submission review process for medical device manufacturers.Sean Fenske, Editor 11.06.17
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Testing
Sterigenics International Acquires Toxikon’s European Laboratory Business
Purchase creates a global extractables and leachables lab testing platform to serve the medical device industry.Sterigenics International LLC 11.02.17
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R&D & Design | Testing
Mike on Medtech: Human Factors
Mike Drues and Sean Fenske discuss the importance and benefits of human factors design in medical device development.Sean Fenske, Editor 10.09.17
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Packaging & Sterilization | Testing
Packaging Validations—Looking Beyond ISO 11607
Most discussions on packaging validations for medical devices begin and end with ISO 11607: Packaging for Terminally Sterilized Medical Devices, and are laden with interpretations of how the two parts of this standard apply best to the unique aspects…Christopher Scott, Vice President, Eurofins Medical Device Testing 10.05.17
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Testing
So We’re All on the Same Page: You Need a Test Plan
I’m a huge fan of lists. Covering every base with an organized way to track everything from my companies’ financial progress to whether the Doritos made it into the car for the drive home from school keeps me functioning. I note things on…Dawn A. Lissy, Empirical 09.01.17
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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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Contract Manufacturing | R&D & Design | Software & IT | Testing
5 Tips to Avoid a Clinical Trial Failure
A failed data strategy in medical device trials can be costly for a number of reasons.Online Exclusives Paul Fardy, VP of Data Services, CROS NT 08.01.17
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3D/Additive Manufacturing | Contract Manufacturing | Machining & Laser Processing | Materials | Molding | R&D & Design | Testing
Testing Designs: Prototypes Help Get Medtech to Market Faster
Both traditional and advanced prototyping technologies are seeing increased use to get products to market faster.Mark Crawford, Contributing Writer 07.26.17
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3D/Additive Manufacturing | R&D & Design | Testing
Pro Tips for Prototypes: The Smart Way to Manage Device Iterations
There’s something about hitting the prototype stage of the development cycle that makes everything finally seem real. This is the point at which there is finally an object to hold in your hands—a physical representation of the vision, inv…Dawn A. Lissy, Empirical 07.26.17
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Testing
Discussing the UL/Emergo Merger: A Q&A
Representatives from both firms speak about the transaction, the expected benefits, and what’s ahead.Online Exclusives Sean Fenske, Editor 06.20.17
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Digital Health | Software & IT | Testing
Recent Cyber Attack Enough to Make Medtech WannaCry
It was the U.S. Food and Drug Administration’s (FDA) worst nightmare come true. On May 12, the WannaCry ransomware cryptoworm slithered its way into computers worldwide, infecting as many as 200,000 Microsoft Windows systems in 150 countries…Michael Barbella, Managing Editor 06.06.17
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Digital Health | R&D & Design | Software & IT | Testing
Hire a Hacker
The Internet of Things (IoT) has brought an array of connected technologies that offer a bevy of benefits. From the seemingly superficial, such as a refrigerator that automatically tracks its contents and updates your grocery list appropriately, to t…Sean Fenske, Editor 06.06.17
