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: Regulations/Standards
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: IoMT
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.
Products: Tubing & Extrusion
Linear stepper stages, tubing, Bluetooth modules, and more.
Features: Materials
A robust, optimized mechanical testing program is essential to successful quality control testing.
Supplements: Electronics & Computers
Our 2021 Resource Guide shows you the top manufacturers in materials, manufacturing, and a range of other medical-device categories.
From the Editor: Regulations/Standards
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: Manufacturing & Prototyping
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
While many devices have received Emergency Use Authorization (EUA) for short-term use, new testing procedures are needed for the long-term.
From the Editor: Regulations/Standards
FDA just released the agency’s first action plan addressing artificial intelligence (AI) and machine learning (ML).
Briefs: Medical
The updated standard allows the manufacturer to assess and mitigate risks that are associated with correct use and use errors.
Products: Mechanical & Fluid Systems
Magnetic angle sensors, heat-staking platforms, regulatory software, and more.
Features: Regulations/Standards
Philip Nelson, a partner with Knobbe Martens, provides some insights for device companies facing challenges with intellectual property.
From the Editor: Regulations/Standards

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

Features: Medical
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.
Briefs: Regulations/Standards

In 2018, an update on regulations for respiratory medical devices meant that volatile organic compounds (VOCs) emitted from the devices...

Features: Medical

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

Briefs: Medical

Ovarian cancer is usually diagnosed only after it has reached an advanced stage, with many tumors spread throughout the abdomen. Most patients undergo surgery to remove as many of...

Features: Test & Measurement

The Luer connector is arguably one of the most important developments in the biomedical industry. Because it is reliable, simple to use, and economical to produce, the Luer connector...

News: Test & Measurement

As of September 2018, Instron’s Calibration Laboratory in Norwood, MA USA (NVLAP Lab Code 200301-0) expanded its global reach to include Europe into its existing operations. This...

Features: Electronics & Computers

Meeting the requirements for patient-connected medical devices can present challenges for power system designers. There are several key elements to consider, including isolation,...

Features: Test & Measurement

The fourth edition IEC/EN 60601-1-2 (4th Edition) will become a mandatory standard covering safety for medical devices on December 31, 2018.1,2 As with any new...

Features: Medical
INSIDER: Manufacturing & Prototyping

A grant from the National Institute of Standards and Technology (NIST) will be used to to develop standards for regenerative medicine and biomaterial manufacturing. NIST...

Features: Packaging & Sterilization

A key driver of the medical disposables market is the desire to minimize the risk of healthcare-associated infections (HAIs). Healthcare providers are turning to disposable...

News: Test & Measurement
Medical Device Preclinical Bootcamp to Explore Testing Pathway

An upcoming seminar will explore the preclinical testing pathway for medical devices. The event will cover everything from concept to regulatory submission, including relevant regulations and standards, as well as the role each type of test plays in the overall testing program. It...

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.

Trending Stories

Applications: Manufacturing & Prototyping

Why Cleanroom Assembly of Plastic Medical and Electronic Devices Requires...

Features: Regulations/Standards

Establishing Proper Validation of Extruded Silicone Tubing