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.

Stories

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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...
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Technology Leaders: Electronics & Computers
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: 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 dimensional, shape, and positional deviations...
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Features: Regulations/Standards
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...
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News: Test & Measurement
To find out more about the expertise required to establish safe processes for cleaning and disinfecting reusable medical devices, MDB recently spoke with Christopher Scott, Vice President of Eurofins Medical Device Testing (Lancaster, PA).
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Technology Leaders: Medical
When the Medical Device Regulation (MDR) replaces the Medical Device Directive (MDD) in 2020, requirements for medical devices in Europe...
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Features: Electronics & Computers
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 standard edition, there are...
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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 disinfectants....
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Briefs: Materials
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...
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Briefs: Regulations/Standards
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. With...
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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: Regulations/Standards
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 will...
News: Medical
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 holistic customer value...
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 have...
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Features: Test & Measurement
Often, the last thing first-time and even serial entrepreneurs think about is how the result of their...
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Features: Test & Measurement
Manufacturers producing medical devices that involve patient contact are typically required to perform biological safety evaluations, including biocompatibility tests...
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Briefs: Test & Measurement
Researchers at the National Institute of Standards and Technology (NIST) say that manufacturers may soon have a speedy and nondestructive way to test a wide array of materials under real-world...
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Technology Leaders: Connectivity
Smart, connected devices are an increasing reality of daily life. It is estimated that by 2020, there will be 33 billion internet devices in the world—enough for 4...
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Features: IoMT
Imagine you are recovering from an operation and are fitted with wireless body sensors that allow you to move in the hospital bed or around the room in comfort. Once past the...
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Features: Test & Measurement
To design and successfully sell medical devices, manufacturers must ask themselves a number of key questions. What range of functions should this product offer? In what type of...
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Features: Regulations/Standards
The recent publication by the U.S. Food and Drug Administration (FDA) of Guidance for Industry Pyrogen and Endotoxins Testing: Questions and Answers, dated June of 2012, the Department of...
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Features: Test & Measurement
Package validation testing has always been an important aspect of many medical device development processes. Today, it isn’t just new packaging that manufacturers need to worry about —...
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Ask the Expert

John Chandler on Achieving Quality Motion Control
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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

Inside Story: Trends in Packaging and Sterilization
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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.

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