Keyword: Needs assessment

Stories

Features: Regulations/Standards
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.
Features: Software

Orthopedic devices play a crucial role in providing pain relief, improving mobility, and enhancing the quality of life for patients suffering from musculoskeletal...

Features: Internet of Things

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: Medical

As medical devices become smaller, the need for precision microminiature components increases. This provides several challenges for the medical device manufacturer as they seek cost-effective...

Applications: Medical

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
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

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.

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.