Quality & Regulatory Solutions for the FDA Regulated Industries
EMMA International specializes in full-circle solutions for the medical device, biologics, and pharma industries.
Testing
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Testing
The Evolution of Chemical Characterization for Medical Devices
Evaluation of biological safety of devices is experiencing some of the most significant changes in history.Sandi Schaible, Senior Director, Analytical Chemistry and Regulatory Toxicology, WuXi AppTec Medical Device Testing 04.01.21
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Contract Manufacturing | Software & IT | Testing
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Testing
NAMSA Appoints New CEO, Board Chairman
Dr. Christophe Berthoux will begin leading the company March 22; former AdvaMed Chairman Nadim Yared to become NAMSA Chairman.Sam Brusco, Associate Editor 03.15.21
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Testing
Sotera Health Acquires BioScience Laboratories
Strengthens Sotera Health’s antimicrobial and antiviral lab testing capabilities.Charles Sternberg, Assistant Editor 03.11.21
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Testing
Stressed Testing: Challenges with Medical Device Testing
The pandemic has resulted in unprecedented levels of demand for device testing with requests for rapid turnaround times.Mark Crawford, Contributing Writer 03.04.21
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Electronics | Testing
Refurbished Medical Equipment Testing and Certification Under the NEC
The National Electric Code (NEC) has been updated to better ensure refurbished or reconditioned products' safety and performance.Online Exclusives L. Matthew Snyder, Director of Certification, Intertek 02.25.21
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Testing
Element Material Technology Acquires Avomeen
Strengthens its life sciences business unit in North America.Charles Sternberg, Assistant Editor 02.03.21
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Diagnostics | Testing
GenMark Diagnostics’ ePlex RP2 Receives EUA from FDA
Provides results for more than 20 viruses and bacteria in less than two hours.GenMark Diagnostics Inc. 10.09.20
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Testing
Nelipak Facility Earns ISO/IEC 17025 Accreditation
Provides a comprehensive range of testing services to support package testing requirements.Nelipak 09.10.20
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Testing
Assessing Nanoparticles for Biocompatibility
It is important to have an appropriate testing protocol in place for this relatively new medical technology.Helin Räägel, Ph.D., Biocompatibility Expert, Nelson Laboratories 09.01.20
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Diagnostics | Testing
Alliant Offers COVID-19 Antibody Test Kits
Allows individuals to screen for both IgG and IgM strands of the coronavirus.Globe Newswire 07.06.20
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Diagnostics | Testing
Neoteryx's Mitra Device Registered with Australian TGA
Can now be imported into Australia for use in research and clinical diagnostic applications.PRNewswire 06.22.20
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Testing
Going Beyond the Regulations to Evaluate Relevant Medical Device Risk
Companies need to review their testing plan so it supports a successful submission, saves time, and ensures the long-term success of their product.Sherry Parker, Ph.D., Senior Director of Regulatory Toxicology, WuXi AppTec Medical Device Testing 06.04.20
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Testing
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Surgical | Testing
Medical Robots: Assessing Safety and Performance in a Growing Field
Be aware of potential hazards robots may present and testing options to address them.Online Exclusives Bill Stearns, Associate Senior Engineer, Intertek 04.17.20
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Testing
Plastikos and Plastikos Medical Implements ISO 14698
This system is dedicated to test for bio-contamination, and evaluate microbiological data.Plastikos 04.01.20
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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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Testing
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 03.04.20
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Materials | Testing
Particle Particulars: Why this Analysis Is Foundational for Successful Devices
In the mid-2000s, medical device experts were hopeful they’d found one solution to longer-lasting implants.Dawn A. Lissy, President & Founder, Empirical 03.04.20
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Testing
Mike on Medtech: Human Factors/Usability, Part 2
Mike Drues and Sean Fenske discuss the implications of not meeting with the FDA’s requirements for human factors testing.Sean Fenske, Editor-in-Chief 02.03.20
