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
Joint Testing Shows Medical-Grade TPEs Bond Effectively to Copolyesters
Medalist TPEs over-molded onto Eastman Tritan copolyester yielded durable bond for grips, gaskets, and other soft/rigid items.Teknor Apex Company and Eastman 09.07.21
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Testing
Nordson Corp. to Buy NDC Technologies for $180M
NDC expands Nordson’s test and inspection platform beyond electronics into new end markets.Business Wire 08.24.21
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Diagnostics | Testing
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Testing
Guidance on Skin Irritation With a Push to Achieve the 3 Rs
The publication of ISO 10993-23:2021 marks a paradigm shift in prioritizing in-vitro testing alternatives within the medical device biocompatibility space.Nick Hibbard, In-Vitro Scientific Research Fellow at WuXi AppTec Medical Device Testing 07.22.21
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Testing
EAG Expands Medical Device Testing Services With New Lab
The laboratory includes a dedicated medical device polymer analysis area.Business Wire 07.12.21
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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
