Keyword: Risk management

Stories

Briefs: Regulations/Standards
The updated standard allows the manufacturer to assess and mitigate risks that are associated with correct use and use errors.
Features: Electronics & Computers

The medical device industry often looks to independent distributors to address chronic shortages in the availability of electronic components. Direct sourcing of...

Features: Medical

In an industry where people's health and wellness are on the line, manufacturers can't afford to let risk go unaddressed. As the International Organization for...

Technology Leaders: Medical

Staying competitive calls for medical equipment OEMs to constantly keep pace with the speed of innovation. Better medical treatment and care can be achieved with fast,...

Features: Software

FDA’s introduction to its rules for medical device regulation states: “Medical devices are classified into Class I, II, and III. Regulatory control...

Features: Medical

The medical device industry, driven by innovation and new technologies, has become one of the biggest markets in healthcare. The explosion in sophistication and application...

Technology Leaders: Packaging & Sterilization

The market for medical electronics is huge and growing. The astounding capabilities of digital technology and broadband connectivity are “a perfect storm,” enabling doctors...

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...

Features: Connectivity

Cyber threats to health delivery organizations (HDOs) and the medical device industry as a whole have hit a new level of maturity in the last year. A decade ago, the attack scene was...

Features: Electronics & Computers

Printed circuit boards (PCBs) are critical components in many medical devices. Prior to shipment to the OEM, PCBs must undergo a thorough cleaning process to remove excess...

Features: Regulations/Standards

Design validation is one of the most important aspects of the design and development process for medical devices. It is at this stage that the medical device manufacturer confirms that the device...

Features: Regulations/Standards

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

Features: RF & Microwave Electronics

Implementation of IEC 60601-1-2, 4th edition is on the horizon. This collateral standard to the IEC 60601-1 medical safety standard specifies the electromagnetic compatibility (EMC) requirements for...

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...

Features: Electronics & Computers

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...

Briefs: Medical
Medical Device Integrators Can Ensure Data Accuracy and Patient Safety

In the absence of true standards of medical device communication, medical device integration is a proven, reliable solution for accurate and timely delivery of those data to the various systems and applications running throughout a healthcare organization. While some device...

Features: Regulations/Standards

Medical devices manufactured today require significant attention to safety and human factors engineering that has not always been exercised in medical device design. IEC safety...

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...

Features: Tubing & Extrusion

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...

Features: Regulations/Standards

No other industry in the US is under more pressure than medical electronics, and those pressures continue mounting each year for greater innovation and products that...

Applications: Regulations/Standards

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: Medical

Design for Manufacturability (DFM) is a well-established practice, essential in realizing the transformation of new product concepts into mass-produced medical devices. And yet, all too often...

Briefs: Software

The medical industry stands to benefit immensely from cloud-based product lifecycle management (PLM). The mountains of information that medical companies must manage when...

Briefs: Medical
Maintaining Sterility Assurance Level in Medical Device Design

A medical device undergoing design and classified as sterile will be confronted with various obstacles, not the least of which is how to determine and maintain its proposed Sterility Assurance Level (SAL) as it approaches its ultimate goal: delivery to market.

Features: Regulations/Standards
What’s So Hard About Medical Device Software Compliance?

The IEC 62304 standard for medical device software is causing system engineers worldwide to step back and examine their software development methods with considerable scrutiny. Although at one time, software development and testing was an integral part of overall system design and...

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.