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.

Latest Briefs & News

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.

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

Optical Distance Sensor

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

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...

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...

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...

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...

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: Medical
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: 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: Packaging & Sterilization
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...

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...

Often, the last thing first-time and even serial entrepreneurs think about is how the result of...

Manufacturers producing medical devices that involve patient contact are typically required to perform biological safety evaluations, including biocompatibility...

Briefs: Manufacturing & Prototyping
Testing & Quality Control for Nanomanufacturing

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...

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...

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...

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...

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...

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 —...

Ask the Expert

Ralph Bright on the Power of Power Cords

Understanding power system components and how to connect them correctly is critical to meeting regulatory requirements and designing successful electrical products for worldwide markets. Interpower’s Ralph Bright defines these requirements and explains how to know which cord to select for your application.

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