Keyword: Safety testing and procedures

Stories

Features: Manufacturing & Prototyping
See how components suppliers can help therapeutic manufacturers choose the right material for the right application.
Technology Leaders: Test & Measurement
Modern evaluation of biocompatibility uses a risk-based approach.
Briefs: Data Acquisition
Specialized computational algorithms provide for highly efficient DNA sequence 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: RF & Microwave Electronics

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...

Technology Leaders: Medical

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

Briefs: Medical

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....

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...

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...

Technology Leaders: RF & Microwave Electronics

Electromagnetic compatibility (EMC) requirements for medical devices and systems is defined by IEC 60601-1-2. The fourth edition implementation of this EMC...

Features: Packaging & Sterilization

As in any industry, new technologies and material choices present new opportunities and challenges for OEMs looking to build brand...

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...

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...

Applications: Robotics, Automation & Control

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...

Features: Medical

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

Features: Test & Measurement

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

Features: Medical

Giving attention to regulatory considerations at the earliest stages of product design and development can create a smoother and more successful...

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...

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...

Technology Leaders: Medical

Collaboration among healthcare technology stakeholders—from device manufacturers and healthcare delivery organizations to healthcare security intelligence...

Technology Leaders: Medical

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...

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...

Features: Connectivity

Medical device manufacturers operate in a challenging environment filled with stringent regulatory requirements and industry pressures. With a rise in mainstream...

Features: Medical

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...

Briefs: Electronics & Computers
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...

Technology Leaders: Medical

Portable and wearable healthcare devices represent growing, high volume markets for the medtech industry. Patient monitors are evolving from stationary...

Technology Leaders: Electronics & Computers

While a number of countries have standards in regards to overall medical equipment, a few countries have related component requirements (e.g. plugs...

R&D: Medical

Materials scientists at the Friedrich Schiller University of Jena, Germany, have examined implants made of nickel-titanium alloy in a long-term study and have determined that the release of nickel...

Technology Leaders: Electronics & Computers

Every day, medical device manufacturers are getting better and better at managing risk. They know they have to. Changes have been introduced into international regulatory schemes that impact device design...

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.