Keyword: Risk assessments

Stories

Technology Leaders: Test & Measurement
Modern evaluation of biocompatibility uses a risk-based approach.
Briefs: Medical
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: Regulations/Standards

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

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: Test & Measurement

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

Features: Medical

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: IoMT

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

Technology Leaders: Regulations/Standards

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...

Features: Medical

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

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...

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...

Technology Leaders: Medical

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

R&D: Materials

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...

Applications: Materials

Valves are critical components of many disposable medical devices. They are responsible for controlling the movement of fluid, which could be a pharmaceutical or nutritional...

Briefs: Medical

Wireless technology increases the effectiveness of countless every day functions. While some simply are about the convenience factor, like being able to quickly...

Features: Test & Measurement

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...

Applications: Electronics & Computers

For medical device OEMs seeking compliance to the 3rd Edition of IEC 60601-1 for their power supplies, what is quite clear by now are the regional dates for...

Features: Regulations/Standards

Every medical device company faces the challenge of navigating through the FDA’s mandatory regulations, and companies have different needs that change as they mature. Early-stage medical...

Mission Accomplished: Medical

Sudden Cardiac Arrest (SCA) is a leading cause of death in the United States, accounting for an estimated 300,000 deaths each year — more than lung cancer, breast cancer, and HIV/AIDS...

Features: Medical

Most medical device manufacturers must first receive approval from the U.S. Food and Drug Administration (FDA) before they can market a medical device. Device manufacturers must...

Ask the Expert

Dan Sanchez on How to Improve Extruded Components

Improving extruded components requires careful attention to a number of factors, including dimensional tolerance, material selection, and processing. Trelleborg’s Dan Sanchez provides detailed insights into each of these considerations to help you advance your device innovations while reducing costs and speeding time 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.

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