Keyword: Regulations

Stories

Features: Regulations/Standards
Bring your project from the process development phase of manufacturing to a fully validated one.
Features: Packaging & Sterilization
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: Electronics & Computers
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: Regulations/Standards
Understand what part 18 of the 1099318 standard means for your product’s overall life cycle.
Technology Leaders: Manufacturing & Prototyping
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: Manufacturing & Prototyping
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: 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...

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: Packaging & Sterilization

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: Regulations/Standards

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: Regulations/Standards

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: Test & Measurement

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: Design

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: Medical

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...

Features: Medical
MDUFA IV: Shorter Review Times, More Consistency, and More Oversight

The reauthorization of the Medical Device User Fee Amendments (MDUFA) brings more pressure for FDA to shorten its review times back to “historical norms” and to provide more consistency in the review process. And after the success of an independent review authorized in...

Ask the Expert

Eric Dietsch on the Benefits of Nitinol Wire

In collaboration with the Fort Wayne Metals Engineering team, Eric Dietsch focuses on supporting customers with material recommendations, product development, and education. Eric is available to help you and your company with any Nitinol-related questions or needs that you may have.

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.