Testing

Testing

New Proposed Changes to the Standard for Toxicological Risk Assessment

ISO/FDIS 10993-17 provides extensive guidance around risk assessment practices for medical devices.

Kimberly Ehman, Ph.D., DABT, Director of Regulatory Toxicology, WuXi AppTec 07.20.23

Testing

How MicroCT Scanning Can Speed Devices to Market

MicroCT scanning could revolutionize the way we assess the safety and efficacy of medical devices.

Dawn A. Lissy, President, Empirical 06.06.23

Testing

MDR’s Proposed Transitional Deadline Extension Is a Chance for More Rigor

What does this mean for their current timelines and processes?

Mark Cabonce, Principal Toxicologist 03.10.23

Testing

Medical Device Testers Are Caught Up in a Whirlwind

Testing professionals see increasing demand due to changing market needs, revised regulatory standards, sustainability efforts, and sterilization questions.

Mark Crawford, Contributing Editor 03.10.23

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

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

Testing

EnMed MicroAnalytics

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Victoria Tan, Marketing Assistant 11.17.22

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

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

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

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

Testing

Jordi Labs Acquired by RQM+

RQM+ now offers proprietary testing services for extractables and leachables.

Charles Sternberg, Associate Editor 09.07.22

Testing

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.

Sponsored released by Eurofins Medical Device Testing 09.07.22

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

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.

Sponsored released by KMC Systems 08.15.22

Testing