Keyword: Regulations

Stories

Features: Mechanical & Fluid Systems
Although the pandemic has delayed the MDR’s validation date, it has not diminished the importance of this new regulation.
Features: Regulations/Standards
Bring your project from the process development phase of manufacturing to a fully validated one.
Features: Medical
As medical devices become more advanced and innovative, so do the regulations that surround them.
Features: Manufacturing & Prototyping
Developing IFUs for reusable devices presents a unique challenge that requires focused attention to ensure patient safety: the reprocessing method.
Briefs: Regulations/Standards
Deadlines are approaching for compliance.
Technology Leaders: Motion Control
Medical pipettes, syringes, and mesotherapy devices often move loads linearly instead of rotationally.
Technology Leaders: Materials
An objective screening matrix to enable medical device manufacturers in identifying the appropriate material for device assemblies.
Features: Medical
Understand what part 18 of the 1099318 standard means for your product’s overall life cycle.
Technology Leaders: Medical
Weighing your testing options is imperative to submission success.
Features: Design
Having a strong business plan can provide a resilient foundation for successful medical device innovation.
Features: Materials
Learn how liquid silicone rubber (LSR) is playing a major role in the fabrication of new medical devices.
Features: Medical
A number of manufacturers are still in the process of confirming who qualifies as an "Economic Operator."
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: Medical
Why Class I manufacturers should not place European Medical Device Regulation (EU MDR) compliance at the end of their to-do lists.
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...

Features: Tubing & Extrusion

In an effort to design smaller, more intricate and complicated medical devices without running afoul of increasingly stringent national and international regulations, many designers are...

Briefs: Medical

In 2018, an update on regulations for respiratory medical devices meant that volatile organic compounds (VOCs) emitted from the devices...

Features: Medical

Updates to ISO 11607, Parts 1 and 2, have left many medical device manufacturers wondering about the future of their packaging designs. These changes come at a stressful...

Features: Medical

Companies regulated by the U.S. Food and Drug administration (FDA) need to establish current good manufacturing practices (CGMPs) as part of Title 21 CFR part 820 requirements. This...

Features: Medical

The myriad of devices used in surgical, interventional, imaging, diagnostic and therapeutic, sensors, and single-use medical applications use some form of transmission medium...

Features: Manufacturing & Prototyping

Vital for ensuring compliance to federal regulations, dimensional metrology systems facilitate critical measurement of medical parts, and force testing systems are used to...

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

Calibration of a device is carried out to minimize the uncertainty in measurements. It helps in reducing the errors and brings the measurement to an acceptable level....

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....

Features: Regulations/Standards

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...

Features: Regulations/Standards

When ISO 9001 was produced by the International Standards Organization, it put forth the general quality standard that organizations could adopt to ensure that the organization is focused on...

Features: IoMT

As medical technology accelerates at an almost incomprehensible pace, regulations and requirements increase correspondingly. With rapid innovation and the desire to speed time to market comes more rigorous...

Features: Medical

We are living through an era of profound change. Technology is affecting this change in ways unthinkable only a decade ago and none more so than in the medical device industry. A tour of life...

From the Editor: Medical

As 2016 came to a close, the U.S. House of Representatives overwhelmingly approved the 21st Century Cures Act by a vote of 392–26, and the Senate passed it by a vote of...

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.

Trending Stories

Technology Leaders: Regulations/Standards

First, Do No Harm: Changing Strategies to Prove Your Medical Device Is Safe