News: Regulations/Standards

Movano Health, Pleasanton, CA, has announced successful preliminary results of its pivotal hypoxia trial, which was completed in conjunction with the...

Supplements: Software
In our summer edition of the MDB Resource Guide, learn about new cleaning requirements and find the right company to match your medical-design needs.
Supplements: Mechanical & Fluid Systems
In our summer edition of the MDB Resource Guide, learn about new cleaning requirements and find the right company to match your medical-design needs.
Technology Leaders: Test & Measurement
Modern evaluation of biocompatibility uses a risk-based approach.
Features: Medical
Bring your project from the process development phase of manufacturing to a fully validated one.
From the Editor: Connectivity
New best practices for understanding medical device security.
Supplements: Sensors/Data Acquisition
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: Software
A robust, optimized mechanical testing program is essential to successful quality control testing.
Briefs: Regulations/Standards
Deadlines are approaching for compliance.
Supplements: Manufacturing & Prototyping
Our 2021 Resource Guide shows you the top manufacturers in materials, manufacturing, and a range of other medical-device categories.
Features: Regulations/Standards
While many devices have received Emergency Use Authorization (EUA) for short-term use, new testing procedures are needed for the long-term.
Features: Regulations/Standards
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.
Features: Regulations/Standards
The COVID-19 pandemic has ushered in a new period of growth for wearables.
From the Editor: Regulations/Standards
FDA just released the agency’s first action plan addressing artificial intelligence (AI) and machine learning (ML).
Products: Mechanical & Fluid Systems
Magnetic angle sensors, heat-staking platforms, regulatory software, and more.
From the Editor: Regulations/Standards
When the Emergency Use Authorization Act is lifted, the FDA will have a real device review in place, says our guest editor.
Applications: Manufacturing & Prototyping
To produce an additively manufactured prosthesis, REJOINT starts by 3D modelling the patient’s CT scan.
Features: Medical

As summer 2020 gives way to fall and we continue grappling with unprecedented challenges, healthcare industry efforts persist to ensure that medical supplies are available when and where they are...

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
Philip Nelson, a partner with Knobbe Martens, provides some insights for device companies facing challenges with intellectual property.
From the Editor: Wearables

FDA has issued multiple emergency use authorizations, loosened regulations for telemedicine, and eased the requirements for production...

Blog: Medical

The U.S. Food and Drug Administration (FDA) has established new program specifically geared toward expediting the development of potentially safe and effective...

From the Editor: Regulations/Standards
FDA has kicked off a new voluntary electronic submission program for 510(k)s.
Blog: Design

The U.S. Food and Drug Administration (FDA) has made policy changes to respond to the urgent need for even faster testing availability. Although laboratories could use the EUA...

Blog: Medical

FDA is postponing most foreign and domestic inspections through April, effective immediately. Inspections outside the U.S. deemed mission-critical will still be considered on a...

From the Editor: Regulations/Standards

FDA says it is continuing to advance its scientific and technical capabilities, but a recent New York Times editorial says the agency is in...

From the Editor: Medical

As a first step toward implementation of its recently established Safety and Performance Based Pathway for medical devices, FDA is issuing draft guidances outlining the...

From the Editor: Software

The test phase of FDA’s Software Precertification (Pre-Cert) Program has hit its halfway point. The agency has released an update on its progress and the...

Features: Manufacturing & Prototyping

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

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