Testing

Testing Procedures

To meet your manufacturing standards, learn how to implement medical device testing strategies, including automation, validation, and verification of components and the manufacturing process.

Features: Materials
Learn the key parameters for evaluating the chemical resistance of your materials.
Features: Regulations/Standards
While many devices have received Emergency Use Authorization (EUA) for short-term use, new testing procedures are needed for the long-term.
News: Test & Measurement

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

News: Medical

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...

INSIDER: Test & Measurement

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...

Features: Test & Measurement
Engineers are thinking of creative ways to design a packaging system that will ensure safe arrival of a medical device.
Products: Connectivity
Simulation Software

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

Products: Software
Shielding materials, static control, 3D printing software, and more.
Blog: Test & Measurement

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

Blog: Test & Measurement

“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...

Blog: Medical

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...

Blog: Test & Measurement

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

Features: Test & Measurement
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.
Technology Leaders: Medical

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...

Technology Leaders: Test & Measurement
Learn about 2019's stand-out manufacturers and cutting-edge applications in special metals, coatings, robotics, and more.
News: Medical

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

Products: Electronics & Computers
Optical Distance Sensor

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

Features: Test & Measurement

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...

News: Test & Measurement
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...

Technology Leaders: Medical

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

Features: Medical

The fourth edition IEC/EN 60601-1-2 (4th Edition) will become a mandatory standard covering safety for medical devices on December 31, 2018.1,2 As with any new...

Features: Packaging & Sterilization

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...

Briefs: Test & Measurement

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...

Briefs: Test & Measurement

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....

News: Test & Measurement
Nelson Labs Expands Itasca Lab Operations and Testing Capabilities

Nelson Laboratories, LLC, a Sotera Health company, has made significant investments to expand the operations and service capabilities at its Itasca, IL, laboratory facility to better service customers.

News: Test & Measurement
Medical Device Preclinical Bootcamp to Explore Testing Pathway

An upcoming seminar will explore the preclinical testing pathway for medical devices. The event will cover everything from concept to regulatory submission, including relevant regulations and standards, as well as the role each type of test plays in the overall testing program. It...

News: Test & Measurement
Biocompatibility Expert to Discuss Successful Sample Preparation for Medical Device Testing

Properly prepared test articles are critical for accurate biocompatibility testing. As a sponsor of a medical device, it is imperative for medical device manufacturers to understand what to do to ensure a successful test of a proposed medical device.

News: Test & Measurement
Sterigenics International Changes Name to Sotera Health

Sterigenics International has changed its parent company name to Sotera Health. Its three operating companies — Nelson Labs™, Nordion®, and Sterigenics® — will continue to maintain their current names. The new parent company name signals a more integrated and...

Features: Design

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...

Ask the Expert

John Chandler on Achieving Quality Motion Control

FAULHABER MICROMO brings together the highest quality motion technologies and value-added services, together with global engineering, sourcing, and manufacturing, to deliver top quality micro motion solutions. With 34 years’ experience, John Chandler injects a key engineering perspective into all new projects and enjoys working closely with OEM customers to bring exciting new technologies to market.

Inside Story

Rapid Precision Prototyping Program Speeds Medtech Product Development

Rapid prototyping technologies play an important role in supporting new product development (NPD) by companies that are working to bring novel and innovative products to market. But in advanced industries where products often make use of multiple technologies, and where meeting a part’s exacting tolerances is essential, speed without precision is rarely enough. In such advanced manufacturing—including the medical device and surgical robotics industries — the ability to produce high-precision prototypes early in the development cycle can be critical for meeting design expectations and bringing finished products to market efficiently.

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