Features: Regulations/Standards
Although the pandemic has delayed the MDR’s validation date, it has not diminished the importance of this new regulation.
Technology Leaders: Materials
Modern evaluation of biocompatibility uses a risk-based approach.
Features: Regulations/Standards
Bring your project from the process development phase of manufacturing to a fully validated one.
From the Editor: Regulations/Standards
New best practices for understanding medical device security.
Supplements: Manufacturing & Prototyping
In our winter edition of the MDB Resource Guide, learn about new cleaning requirements and find the right company to match your medical-design needs.
Features: Regulations/Standards
A robust, optimized mechanical testing program is essential to successful quality control testing.
Products: Materials
Linear stepper stages, tubing, Bluetooth modules, and more.
Briefs: Regulations/Standards
Deadlines are approaching for compliance.
Supplements: Robotics, Automation & Control
Our 2021 Resource Guide shows you the top manufacturers in materials, manufacturing, and a range of other medical-device categories.
From the Editor: Medical
FDA has created a “Catalog of Regulatory Science Tools,” in which it provides a comprehensive list of peer-reviewed resources for medical device developers.
Features: Test & Measurement
While many devices have received Emergency Use Authorization (EUA) for short-term use, new testing procedures are needed for the long-term.
Features: Aerospace
The "Evolving To MedDev" 2021 digital event will provide automotive and aerospace companies with practical information about how they can enter into the medical device supply chain.
Technology Leaders: Regulations/Standards
There are no true "medical robots," says an industry expert. Here's why.
Briefs: Regulations/Standards
Regulatory changes have allowed these essential healthcare professionals to step in and help out more independently.
From the Editor: Regulations/Standards
FDA just released the agency’s first action plan addressing artificial intelligence (AI) and machine learning (ML).
Blog: Medical

Yes, there will be a day when the U.S. EUA, Emergency Use Authorization Act, will be lifted, the medical device industry goes back to reality, and the FDA regains control of the medical approval process...

Features: Regulations/Standards
A number of manufacturers are still in the process of confirming who qualifies as an "Economic Operator."
Features: Regulations/Standards
Philip Nelson, a partner with Knobbe Martens, provides some insights for device companies facing challenges with intellectual property.
Features: Medical
Why Class I manufacturers should not place European Medical Device Regulation (EU MDR) compliance at the end of their to-do lists.
Features: Test & Measurement
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.
Blog: Medical

The U.S. Food and Drug Administration (FDA) took action May 25, 2020, to make more ventilators available to healthcare personnel in the United States. FDA issued an emergency use...

Blog: Regulations/Standards

The U.S. Food and Drug Administration took significant action to help increase the availability of ventilators and accessories, as well as other...

Blog: Regulations/Standards

On Wednesday, March 25, 2020 (3–4 p.m. Eastern), the U.S. Food and Drug Administration (FDA) will host a virtual Town Hall for clinical laboratories and commercial...

Blog: Regulations/Standards

The Food and Drug Administration (FDA) has issued a new guidance to provide a policy to help expand the availability and capability of noninvasive remote monitoring devices to facilitate...

Blog: Regulations/Standards

The U.S. Food and Drug Administration (FDA) has taken two additional significant diagnostic actions during the coronavirus outbreak (COVID-19)...

From the Editor: Medical

Under new rules to market medical devices in the European Union (EU), only 27 percent of respondents said they will be fully compliant with the...

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...

From the Editor: Medical

Spurring Innovation of Brain-Computer Interface Devices FDA is continuing to encourage innovation in novel areas — the latest being novel brain implants, often...

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....

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.