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Learn about FDA medical device regulations and how to achieve approval. Our news and expert advice provides an overview of regulatory requirements for Class I, Class II, and Class III devices.
Device Enables Thought-Controlled Walking After Spinal Cord Injury
AI Tool Predicts Onset of Parkinson’s Disease
ECG Patch Paves Way for Sustainable Wearables
Medical Devices in the Locker Room
Mactac Acquires Label Supply, Canadian Distributor of Roll Label Products
Movano Health, Pleasanton, CA, has announced successful preliminary results of its pivotal hypoxia trial, which was completed in conjunction with the...
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...
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...
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.
5 Ways to Test Wearable Devices
Powering Medical Devices: How to Filter Noise Out While Keeping Safety In
High-purity Silicone Adhesive Solutions for Medical Device Assembly
Here's an Idea: Real-Time Remote Heart Monitoring
A Look Into New Silicone Elastomers for Low-Temperature Biopharma Applications
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.
