Supply Chain / Testing | Medical Product Outsourcing

Testing

Headline-Generating Medical Device Safety Concerns—Mike on Medtech

Mike Drues and Sean Fenske discuss some recent news about unsafe medical devices and falsified test data.

Sean Fenske, Editor-in-Chief 05.02.24

Testing

Data Integrity: Prepare for Change

What medical device companies should consider when submitting data to the FDA for approval.

Online Exclusives Christopher Scott, Medical Device Industry Consultant 04.12.24

Testing

A Look at Machine Vision in Medtech—#ThrowbackThursday

While likely underutilized in 2000, with the growing interest in automation, machine vision is a critical system today.

Online Exclusives Sean Fenske, Editor-in-Chief 03.21.24

Testing

SGS Laboratory Earns ISO/IEC 17025:2017 Certification

Location in Fairfield, N.J. gains accreditation for its chemical and in vitro cytoxicity testing capabilities.

Sean Fenske, Editor-in-Chief 03.11.24

Testing

Bioscension Opens a New Bioscience Testing Lab

The new lab is located in Miamisburg, Ohio, and promotes access to more economical bioscience testing.

Rachel Klemovitch, Assistant Editor 03.06.24

Testing

Evaluations for the EU: The Impact on Testing & Lab Services

MDR requirements are driving many OEM requests for testing and laboratory services to ensure compliance with the new regulations.

Mark Crawford, Contributing Editor 02.28.24

Packaging & Sterilization | Testing

Charter Signing Aligns Packaging, Sterilization, Laboratory Capabilities

The West Coast Device Alliance aims to unite independent companies that provide capabilities to medical device manufactures for more efficient service.

Videos Sean Fenske, Editor-in-Chief 02.08.24

Testing

The Indispensable Human Touch: The Vital Role of Humans in AI-Powered Medical Technologies

AI emerges as a transformative force, revolutionizing the medtech industry.

Online Exclusives John Hearty, Vice President, IDA Ireland, Mountain View, Calif 01.26.24

Testing

ProDevLabs Establishes New Headquarters in MA

The 5000 square foot facility accommodates the company’s 8 employees with room to expand.

Charles Sternberg, Associate Editor 01.10.24

Contract Manufacturing | Testing

Veranex Purchases Preclinical Testing Firm T3 Labs

The deal adds T3 Labs to Veranex's PCS France preclinical service offering, expanding the company’s global reach.

Sam Brusco, Associate Editor 12.13.23

Testing

Millstone Medical Outsourcing Moves Testing Services into Expanded Facility

The move represents a 400% increase in service capacity and is anticipated to be operational early in Q2 2024.

Charles Sternberg, Associate Editor 11.30.23

Testing

Navigating the Q-Sub Program: How Experienced Lab Partners Can Help Streamline Regulatory Submission

The Q-Sub program is an indispensable tool that bridges the gap between innovation and regulation

Sandi Schaible and Kimberly Ehman, Ph.D., WuXi AppTec Medical Device Testing 11.01.23

Testing

Addressing the Presence of Residuals in Manufacturing—A Medtech Makers Q&A

To ensure residuals are not included in device manufacturing process, companies need to be sure they are testing sufficiently.

Sponsored released by Eurofins Medical Device Testing 10.25.23

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