Testing Procedures

Nelson Labs Launches RapidCert™ Biological Indicator (BI) Sterility Testing

Nelson Laboratories, LLC, a business unit of Sotera Health Company and provider of outsourced microbiological and analytical chemistry testing and advisory...

Addressing Challenges in Primary Packaging Testing for Medical Devices

Developing and evaluating primary packaging for medical devices continues to be an area ripe for innovation, with ample opportunity to improve existing processes. Read on to learn more about the topic.

Inside Story: Trends in Packaging and Sterilization

Eurofins Medical Device Testing (MDT) provides a full scope of testing services. In this interview, Eurofins’ experts, Sunny Modi, PhD, Director of Package Testing; and Elizabeth Sydnor, Director of Microbiology; answer common questions on medical device packaging and sterilization.

Video Spotlight on Products and Services

See which products and services the video spotlight is on, including Dotmatics, an integrated scientific informatics platform that supports research and development activities; an autoinjector testing system featuring precise measurement and control capabilities; BD’s Physiojet disposable autoinjector; testing software that takes over the test sequence with determination of the results; Stevanto Group’s technology centers; and more.

New Device Enables More Holistic and Efficient Testing of PPE

A team at Sandia National Laboratories has developed a faster and more comprehensive way of testing personal protective equipment, or PPE. The basic principle: modeling a device...

Summer 2023 Resource Guide

In our summer edition of the MDB Resource Guide, learn about new cleaning requirements and find the right company to match your medical-design needs.

FDA Pilot Program Supports Streamlined Regulatory Submission Processes for Medical Device Manufacturers

The current U.S. regulatory framework for medical devices under the Center for Devices and Radiological Health (CDRH) includes extensive...

Eliminating Rabbit Testing in the Year of the Rabbit: Alternatives for Animal Testing in 2023

In recent years, ethical concerns over the use of live animals in testing have been increasing, particularly for cases not directly related to advancing human health.

Medical Design Briefs: 2022 Technology Leaders

Learn about the medical manufacturers and cutting-edge applications that stood out in 2022.

Winter 2022 Resource Guide

In our summer edition of the MDB Resource Guide, learn about new cleaning requirements and find the right company to match your medical-design needs.

Standard Test Method for Evaluation of Chemical Resistance of Thermoplastics for Non-Disposable Medical Devices – A Voice from Industry Collaboration Through the COVID-19 Pandemic

Disinfectant formulations tend to be comprised of an active ingredient, a solvent or aqueous carrier solution, and additional constituents that enhance the formulation’s properties.

AI-Enabled Optical Fiber Sensor Device Monitors Brain Injury

The results from tests on animal brain tissues suggest it could help clinicians to better monitor both disease progression and patients’ response to treatment than is currently possible.

Peeling Back the Layers: Adhesives Testing for Wearables

Trends in wearable technology follow those of the broader biomedical and electronics industries — devices are getting smaller, smarter, and easier to use. Specifically, wearables in...

Additive Manufacturing: New Frontiers for Production and Validation

Over the last few decades, additive manufacturing (AM)/ 3D printing has fundamentally changed the way that manufacturers approach product development. Industry is now...

On the Rise: Wearable Injector Systems

The advent of automatic drug-delivery devices has empowered patients to take their treatments in their own hands.

Impact-Modified Acrylic Copolymers: Evaluating Chemical Resistance

Learn the key parameters for evaluating the chemical resistance of your materials.

Testing Strategies for EUA Devices

While many devices have received Emergency Use Authorization (EUA) for short-term use, new testing procedures are needed for the long-term.

Sotera Health Acquires Montana-Based BioScience Laboratories

Sotera Health, a global provider of mission-critical sterilization and lab-testing and advisory services, has acquired Montana-based BioScience Laboratories. This acquisition expands...

Covestro, Metrex Measure Effects of Disinfectants on PC-Based Materials

Frequent cleaning and surface disinfection — already proven to help reduce the risk of hospital-acquired infections (HAIs) — has become even more critical due to...

COVID-19 Test Produces Rapid Results

A CRISPR-based diagnostic for COVID-19 can produce results in 30 minutes to an hour, with similar accuracy as the standard PCR diagnostics now used. STOPCovid could be made cheaply enough that people...

Medical Device Package Testing: Developing a Test Plan that Avoids Product Launch Delays

Engineers are thinking of creative ways to design a packaging system that will ensure safe arrival of a medical device.

New Products and Services

Simulation Software Volume Graphics, Charlotte, NC, has added and augmented important functionalities to its software that help designers and manufacturers capture and interrogate product data to improve final...

New Products and Services

Shielding materials, static control, 3D printing software, and more.

New Study Ranks Performance of Currently Available COVID-19 Antibody Tests

A new peer-reviewed study by researchers at NSF International and Novateur Ventures finds significant variability in the accuracy of currently available COVID-19...

COVID-19: Researchers Adapt Portable, Reusable Test Developed for Zika Virus

“Testing, testing, testing.” It’s a mantra that health officials have been constantly promoting because screening people for COVID-19 is the best way to contain...

Scientists Make Groundbreaking Development in Rapid Large-Scale Testing of COVID-19

OU Medicine, the OU Health Sciences Center, and the Oklahoma Medical Research Foundation collaborated to create a new test for COVID-19 using technology and...

Lab Experts Can Fill Gaps in FDA Regulation by Validating COVID-19 Antibody Tests

Now that diagnostic companies can sell COVID-19 antibody tests without FDA authorization, healthcare teams should work closely with clinical laboratory experts to...

Your MDR Strategy: Start with a Gap Analysis

How to make sense of the 566-page Medical Device Regulation (MDR). This article focuses on a strategy to address material information and what should be included in a gap analysis.

Preparing for MDR? Don’t Overlook the Analytical Evaluation Threshold

Medical device manufacturers have a big challenge in preparing for their regulatory device submissions for 2020. In addition to the European Union’s new Medical Device...