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.

News: Regulations/Standards

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

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White Papers: Medical
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Get the Inside Story on Package Testing

Creating an appropriate testing plan for package performance testing compliant with international regulations is of utmost importance for safely shipping and transporting medical devices. To find out...

Features: Test & Measurement
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.
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Supplements: Medical
Learn about the medical manufacturers and cutting-edge applications that stood out in 2022.
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White Papers: Medical
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Get the Inside Story on EO Residuals

Many factors impact Ethylene Oxide (EO) Residual levels following sterilization, making it difficult to determine when a medical device is safe for public use. In our latest Inside Story, Leonard Harris,...

White Papers: Medical
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Get the Inside Story on EO Sterilization

Ethylene Oxide (EO) Sterilization for many medical devices, may be the only method that effectively sterilizes and does not damage the device during the sterilization process. In our latest Inside...

Supplements: Sensors/Data Acquisition
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.
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Features: Medical
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.
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Briefs: Test & Measurement
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.
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Briefs: Medical

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...

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Features: Medical

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

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Features: Design
The advent of automatic drug-delivery devices has empowered patients to take their treatments in their own hands.
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Features: Materials
Learn the key parameters for evaluating the chemical resistance of your materials.
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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.
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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...

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News: 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...

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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...

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

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Products: Manufacturing & Prototyping
Shielding materials, static control, 3D printing software, and more.
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Blog: Medical

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

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Blog: Design

“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...

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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...

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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...

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Features: Regulations/Standards
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.
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Technology Leaders: Test & Measurement

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...

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

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

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Products: Sensors/Data Acquisition
Optical Distance Sensor

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

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Ask the Expert

Eric Dietsch on the Benefits of Nitinol Wire
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In collaboration with the Fort Wayne Metals Engineering team, Eric Dietsch focuses on supporting customers with material recommendations, product development, and education. Eric is available to help you and your company with any Nitinol-related questions or needs that you may have.

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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