Testing Procedures

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...

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 the...

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: September 2020 Medical Design Briefs

Simulation Software

Volume Graphics, Charlotte, NC, has added and augmented important functionalities to its software that help designers and manufacturers capture and...

New Products and Services: August 2020 Medical Design Briefs

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...

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...

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...

Medical Design Briefs: 2019 Technology Leaders

Learn about 2019's stand-out manufacturers and cutting-edge applications in special metals, coatings, robotics, and more.

Gibraltar Laboratories Changes Name to Nelson Labs Fairfield

Gibraltar Laboratories will officially become Nelson Labs January 3, 2020. Nelson began implementing changes to facilitate the integration of the Gibraltar labs facilities in...

New Products & Services: June 2019 Medical Design Briefs

Optical Distance Sensor

A highly accurate optical distance sensor is available from Werth Messtechnik, Giessen, Germany. The Werth Chromatic Focus Point sensor can measure...

Luer Connectors: Testing to the New International Standard

The Luer connector is arguably one of the most important developments in the biomedical industry. Because it is reliable, simple to use, and economical to produce, the Luer connector...

Inside Story: Eurofins Medical Device Testing

Ensuring Reusable Devices Are Safe for the Next Patient

Advances in manufacturing technologies are fostering an age of unprecedented innovation in the development of reusable medical devices...

Got Your Game Plan? The OEM Playbook to Navigating Preclinical Device Testing Under MDR and ISO 10993-1

When the Medical Device Regulation (MDR) replaces the Medical Device Directive (MDD) in 2020, requirements for medical devices in Europe...

EMC for Medical Devices: EN/IEC 60601-1-2, 4th Edition

The fourth edition IEC/EN 60601-1-2 (4^th Edition) will become a mandatory standard covering safety for medical devices on December 31, 2018.^1,2 As with any new...

Four-Step Plastic Testing Protocol: Making Informed Design and Material Decisions

Medical devices across the United States must not only keep pace with advances in technology but also with the increased use of harsh solvents and...

Tests Prove Immersion Method of Production of Implantable Devices is Effective

Healthcare-associated infections (HAI) are a major, yet often preventable threat to patient safety, and they can have a significant impact on the survival rate of...

Guide to FDA Requirements and Importance of Medical Device Calibration

Calibration of a device is carried out to minimize the uncertainty in measurements. It helps in reducing the errors and brings the measurement to an acceptable level....

Validating IFUs for Reprocessed Medical Devices

Incidents of nosocomial or healthcare acquired infections (HAIs) and bacteria that have become resistant to antibiotics (“superbugs”) are a concern for U.S. FDA. These ongoing incidents...