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Biocompatibility & Testing
Lessons from the Lab: Testing Orthopedic Devices
Changes in testing protocols and revised regulatory demands make testing experts even more valuable than they’ve ever been.Sean Fenske, Editor-in-Chief 09.15.20
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Biocompatibility & Testing
Avoiding Contradictions: Testing Advice for Manufacturers
Manufacturers need to evaluate their approach to preclinical testing. Avoiding contradictory study design is the most effective path forward for study sponsors.Mark R. Cunningham, Ph.D., Senior Director of Science and Technology, Technical Services, WuXi AppTec 08.11.20
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Design
The Importance of Usability/Human Factors Testing
When is the work of human factors over, and how does your team know they are prepared for summative testing?Maria Shepherd, President and Founder, Medi-Vantage 03.13.20
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Biocompatibility & Testing
Making the Grade: A Testing and Analysis Roundtable
This roundtable discussion examines the technological and regulatory factors affecting the third-party testing and analysis services industry.Sam Brusco, Associate Editor 09.17.19
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Biocompatibility & Testing
Why Big Companies With Internal Labs Should Outsource Testing
Most of us know when we’ve hit that line signaling we’ve left our cutting edge and officially spread ourselves too thin. Pushing to do and be more is often a half-step from maxing out and dropping all those balls we’re juggling.…Dawn A. Lissy, President & Founder, Empirical 03.29.19
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Biocompatibility & Testing
Testing in a Rapidly Changing World
OEMs seek risk assessment of their devices while regulatory scrutiny focuses on data and new requirements.Mark Crawford, Contributing Writer 09.19.18
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Biocompatibility & Testing
Testing…Testing…Is This Thing On? Should You Outsource Device Testing or Keep it In-House?
When people ask me what I do, I often reply, “I break things for a living.” Yes, I say it with tongue firmly in cheek. That’s a gross oversimplification of a business I’ve been in for almost 20 years: mechanical testing for…Dawn A. Lissy, President & Founder, Empirical 03.22.17
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Biocompatibility & Testing
New FDA Guidance for 510(k) Submission of Orthopedic Medical Implants
The document could have a significant impact on the testing regimen for implant device manufacturers.Martell Winters, Senior Scientist and Consulting Manager; Quinton Inglet, Section Leader, Bacterial Endotoxin Testing, Nelson Laboratories 11.22.16
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Testing: A Customized Approach
Testing service providers consider each screw, plate and implant as unique as each OEM customer that makes them.Ranica Arrowsmith, Associate Editor 09.15.15
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Machining & Tooling
Fast-Paced Device Development Outpaces Testing Standards
Orthopedic companies outsource to keep up with testing and biocompatibility requirements.02.15.08
