Stories
Features: Regulations/Standards
Features: Packaging & Sterilization
Features: Manufacturing & Prototyping
Briefs: Regulations/Standards
Technology Leaders: Electronics & Computers
Technology Leaders: Materials
Features: Regulations/Standards
Technology Leaders: Manufacturing & Prototyping
Features: Design
Features: Manufacturing & Prototyping
Features: Medical
Features: Regulations/Standards
Features: Medical
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...
Top Stories
INSIDER: Sensors/Data Acquisition

Wearable Health Tech Could Measure Gases Released from Skin
INSIDER: Manufacturing & Prototyping
Micro-CAL Process Prints Fine Features in Glass Microstructures
INSIDER: Medical

Flexible Printable Electrical Patches Accelerate Wound Healing
Inside Story: Design

Inside Story: Rapid Precision Prototyping Program Speeds Medtech Product...
INSIDER: Medical

Real-time Blood Monitor Saves Doctors Critical Time During Surgery
Features: Medical

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.
Webcasts
Webinars: Medical
New Liquid Silicone Rubber with Primerless Adhesion to Polycarbonate
On-Demand Webinars: Medical
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
Features: Mechanical & Fluid Systems

Exploring Valve Technology Requirements Under the New MDR
Mission Accomplished: Electronics & Computers
Diaphragm Pacing Helps Patients with ALS Delay Need for Ventilator
Briefs: Materials

Ultra-High-Molecular-Weight Polyethylene Technology for Minimally Invasive...