The Rapid Evolution of Laboratory Testing for Medical Devices—A Medtech Makers Q&A
Medical device manufacturers need testing partners who can match their pace of innovation with comprehensive solutions.
Testing
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Testing
The Importance of Bioburden Testing
Answering frequently asked questions about bioburden testing for medical device manufacturing.Online Exclusives Steve Gonzales, CEO of Technical Safety Services 12.02.22
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Testing
Millstone Medical Completes MycoScience Acquisition
Adds advanced lab and environmental testing services as well as long-standing industry and regulatory experience.Sam Brusco, Associate Editor 11.18.22
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Testing
Addressing Myths About Extractables/Leachables Testing of Medical Devices
A thorough, thoughtful approach to E/L testing is becoming increasingly important.Sandi Schaible and Peter Steen, WuXi AppTec Medical Device Testing 11.09.22
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Contract Manufacturing | Testing
MMT Acquires Confluent's Medical Equipment Line
Gains balloon forming equipment manufacturing, testing, and catheter manufacturing equipment.Sam Brusco, Associate Editor 11.02.22
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Testing
Changes Related to Cleaning Validations
What medical device manufacturers can expect from ANSI/AAMI ST98.Online Exclusives Alpa Patel, Principal Scientist at Nelson Labs 10.03.22
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Testing
Following the Test Article: Timelines, Expectations for E/L Testing
Complete chemical characterization is a highly technical process that requires collaboration and communication.Zachary Remillard and Sandi Schaible , WuXi AppTec 10.03.22
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Testing
Jordi Labs Acquired by RQM+
RQM+ now offers proprietary testing services for extractables and leachables.Charles Sternberg, Associate Editor 09.07.22
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Testing
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Testing
The Rising Bar for Extractables/Leachables Testing
Unknown chemicals are unacceptable, and experts monitoring regulatory expectations and making quick adjustments are critical.Zachary Remillard and Sandi Schaible , WuXi AppTec 09.01.22
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Testing
Predictive Maintenance for Laboratory Equipment—A Medtech Makers Q&A
The need to ensure the availability of diagnostic technology in terms of keeping it functioning properly has never seemed more important than in recent years.
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Testing
The Complex Regulatory Pathway for Medical Devices and Drug Delivery Systems
Submitting combination products for regulatory review can be complex and confusing.Kim Ehman, WuXi AppTec Medical Device Testing 07.19.22
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Testing
‘Right to Repair’: Separating Fact from Fiction
How a marketplace free of uncompetitive restrictions benefits patients while decreasing costs and improving cybersecurity.Online Exclusives Scott Trevino, Senior Vice President of Cybersecurity, TRIMEDX 06.28.22
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Testing
TÜV SÜD Earns MRI Safety Testing Accreditation
The firm was granted the Scope of Accreditation to ISO/IEC 17025:2017.Sam Brusco, Associate Editor 06.08.22
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Testing
Letting the Light In: How Failure Analysis is the Cornerstone of Success
Failure analysis is a vital part of the process of developing medical devices that function safely and efficiently.Dawn A. Lissy, Founder & President, Empirical 06.01.22
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Testing
Outsourcing vs. In-House Chemical Characterization Testing
Outsourcing pre-clinical safety testing or keeping it in-house is a nuanced and multi-factored decision.Mark Cabonce, MS, DABT and Kim Ehman, Ph.D., DABT, WuXi AppTec 05.02.22
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Testing
Canyon Labs Opens Laboratory in Salt Lake City
Offers services for laboratory testing, scientific and technical consulting, and Institutional Review Board (IRB) clinical support.Charles Sternberg, Associate Editor 04.04.22
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Testing
Medical Device Testing Update: Best Practices for Remaining Up-to-Date
Changes in testing protocols challenge device makers and their service providers to ensure they are keeping up with regulatory requirements.Mark Crawford, Contributing Writer 03.03.22
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Testing
Accelerated Aging ASTM F1980-21 Protocol: Changes and Impact—MPO Videobites
Mark Escobedo of WESTPAK provides an overview of the revisions made to the latest protocol and how they could affect medical device manufacturers.Videos
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Testing
Medical Technology Associates Acquires GasMedix
Gains medical gas services, equipment, and compliance testing.Sam Brusco, Associate Editor 01.19.22
