Testing
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Testing
Study: Medical Device Managers Rely on Physicians to Screen Out Defects Rather Than Issue Recalls
The FDA expressed interest in using this research to improve how they oversee medical device product quality.Indiana University 08.22.18
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Cardiovascular | Neurological | Surgical | Testing
Active Implantable Medical Device Testing: What You Need to Know
Both the implanted product and non-implantable supporting equipment require testing and evaluation to specific standards.Online Exclusives William Stearns, Associate Senior Engineer, Intertek 08.13.18
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Testing
Sotera Health's Nelson Labs Acquires N.J.-Based Gibraltar Laboratories
Strengthens Nelson Labs’ outsourced testing capabilities to better serve the pharmaceutical and medical device industries.Business Wire 08.08.18
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Packaging & Sterilization | Testing
Millstone Medical Welcomes Chief Information Officer to Headquarter Facility
Khrishna Mangal most recently served as a consultant for Paragon Medical.Millstone Medical Outsourcing 07.26.18
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Packaging & Sterilization | Testing
Coming Clean: Developing Standards for Cleaning Reusable Devices and Instruments
Five years ago, I shuddered to read the headlines about “dirty” endoscopes being used in colonoscopies and the speculation that followed. Are colonoscopies really safe? Is this what’s creating new superbugs? Why weren’t hospit…Dawn A. Lissy, President & Founder, Empirical 07.26.18
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Contract Manufacturing | Machining & Laser Processing | Molding | Packaging & Sterilization | R&D & Design | Testing | Tubing & Extrusion
Addressing Peak Issues in Medtech
The 2018 MPO Summit heads to Colorado for discussion, education, and networking.Sean Fenske, Editor-in-Chief 07.26.18
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Contract Manufacturing | Machining & Laser Processing | Testing
Empirical Celebrates 20 Years of Service in the Medical Device Industry
The Empirical family of companies is hosting a 20th anniversary celebration and pig roast Aug. 3-5.Empirical 07.24.18
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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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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
