Keyword: Safety regulations and standards

Stories

Features: Software

Radiation medicine pioneer Elekta is growing fast. In anticipation of regulatory changes requiring more documentation and labeling, the company implemented a...

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.
Technology Leaders: Test & Measurement
With longer lifespans and aging populations worldwide, the need for and importance of dialysis technology will only grow.
Briefs: Manufacturing & Prototyping
Deadlines are approaching for compliance.
Briefs: Medical
This relationship is important to understand when developing the end system.
Technology Leaders: Electronics & Computers
Ventilators are mission-critical to sustaining life and require a robust design to ensure they maintain the necessary up-time for patient care.
Briefs: Manufacturing & Prototyping
Removing organic contaminants and reducing bacterial and viral loads in medical device manufacturing.
Briefs: Design

“Seventy-five percent of all fatal motorcycle accidents globally involve brain injury, with rotational forces acting on the brain being the primary cause of death,” According to NHTSA....

Briefs: Medical

Medical device companies recognize that having an emphasis on design controls helps to assure good design and engineering practices that yield high-quality solutions. This is critical...

Features: Regulations/Standards

FDA’s introduction to its rules for medical device regulation states: “Medical devices are classified into Class I, II, and III. Regulatory control...

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.