Safety

Safety testing and procedures

Stories

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Features: Design
With a view to the absolute safety of patients, medical device manufacturers must be aware of the potential risks of magnetic resonance imaging (MRI).
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Briefs: Imaging
Photoacoustic imaging, which combines optical and acoustic modalities, is enabling some of the most promising medical research.
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Applications: Manufacturing & Prototyping
The SJD Barcelona Children’s Hospital’s pediatric maxillofacial surgery team has used 3D-printing technology to successfully perform a complicated operation to resect a malignant tumor in an 11-year-old boy.
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Briefs: Imaging
Using the device, assorted functional imaging was demonstrated to satisfy clinical needs.
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Features: Medical
See how components suppliers can help therapeutic manufacturers choose the right material for the right application.
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Technology Leaders: Regulations/Standards
Modern evaluation of biocompatibility uses a risk-based approach.
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Briefs: Aerospace
Specialized computational algorithms provide for highly efficient DNA sequence analysis.
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Technology Leaders: Regulations/Standards
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
People and power don’t mix well, and this is particularly true when people are medical patients. Aside from the more usual environment of a medical facility, patients are also...
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Technology Leaders: Test & Measurement
When the Medical Device Regulation (MDR) replaces the Medical Device Directive (MDD) in 2020, requirements for medical devices in Europe...
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Briefs: Manufacturing & Prototyping
More than 95 percent of point-of-care (POC) professionals expect to see an expansion of POC manufacturing enabled by additive manufacturing, commonly called 3D printing....
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Features: Medical
Longer life expectancy in conjunction with improved knowledge of cancers has resulted in increased demands for core needle biopsies. Additionally, cancer diagnosis typically occurs earlier and hence biopsy...
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Features: Medical
For years, anatomical models have played important roles in hospitals and healthcare facilities. From educational aids to practice dummies, these models serve many functions for patients,...
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Technology Leaders: Medical
Electromagnetic compatibility (EMC) requirements for medical devices and systems is defined by IEC 60601-1-2. The fourth edition implementation of this EMC standard is...
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Features: Packaging & Sterilization
As in any industry, new technologies and material choices present new opportunities and challenges for OEMs looking to build brand...
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Features: Medical
Until recently, developers and manufacturers of medical devices have not been required to consider security in their products. New guidance from the U.S. Food and Drug Administration (FDA) and expanded European...
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Features: Medical
In the last three years, there has been an explosion of published content in medical journals related to 3D printing in medicine. This is a great testament to the uptick in innovation and...
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Applications: Medical
The Department of Neurological Surgery at St. Louis University has partnered with the university's School of Engineering to begin quantifying how advanced manufacturing practices such...
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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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Features: Medical
Giving attention to regulatory considerations at the earliest stages of product design and development can create a smoother and more successful pathway...
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Technology Leaders: Medical
It seems the biggest ideas get the most attention, and nothing could be more true than when launching a new medical technology, and/or devices. The development time...
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Technology Leaders: Medical
It is clear that the medical electronics industry has entered an era of dramatic transitions that touch virtually every aspect of the business from...
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Technology Leaders: Medical
Collaboration among healthcare technology stakeholders—from device manufacturers and healthcare delivery organizations to healthcare security intelligence...
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Technology Leaders: Connectivity
After a 20-year effort to establish standards which would minimize the risk of medical misconnections, the pending release of the ISO 80369 series of standards has now...
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Technology Leaders: Materials
Guide wires with a highly lubricious coating are an essential staple of many interventional procedures. In the operating room (OR), you can observe guide wires undergoing multiple passes, constant rotational...
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Features: Medical
Medical device manufacturers operate in a challenging environment filled with stringent regulatory requirements and industry pressures. With a rise in mainstream competitors...
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Features: Regulations/Standards
The third edition of IEC 60601-1 has been in effect since June 2012. It replaces the previous version as a basic standard for medical electrical equipment and describes the general...
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Briefs: Manufacturing & Prototyping
TÜV Urges OEMs to Consider New EMC Requirements
The International Electrotechnical Commission, Geneva, Switzerland, introduced the fourth edition of IEC 60601-1-2:2014, the standard specifying electromagnetic compatibility (EMC) requirements and tests for medical equipment and systems. TÜV Rheinland, a leading global certification organization,...

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

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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