Explore the critical role of electronics cleaning validation in medical device manufacturing. Learn about regulatory requirements, contamination risks, and effective cleaning methods.
Vapor degreasing emerges as a superior cleaning method for complex medical electronics, ensuring regulatory compliance.
Proper electronics cleaning validation is critical for patient safety as medical devices become increasingly miniaturized.
Structured IQ/OQ/PQ validation framework essential for medical device manufacturers facing heightened regulatory scrutiny.
The choice between custom and off-the-shelf electromagnetic sensors in medical devices can have an impact on product development and market performance.
As electromagnetic (EM) sensors become core components in next-generation wearables, implants, and neurotech devices, product designers face a deceptively simple yet critical choice early in development: should they rely on off-the-shelf components or pursue a custom solution?
Guest Editorial: The Power of One When Choosing Stent and Catheter Partners
As device designs become increasingly sophisticated, medtech companies are understandably seeking contract design and manufacturing partners that can accompany them on comprehensive product journeys — from initial concept to validation to large-scale manufacturing, and everything in between. This places a differentiating premium on partners with the ability to combine ideation and early-stage development with materials science and process technologies.
Proof of Life: The Rapid Evolution of Biosensors for Fitness, Health, and Wellness
Biosensors are devices that can monitor physiological states, like heart rate or blood pressure, or detect biological parameters such as glucose levels or the presence of specific proteins in the blood.
U.S. Tariffs: Implications and Strategies for Medtech Manufacturers
In a dramatic shift that could reshape the medical device industry, the U.S. government’s sweeping tariff hikes — particularly a 125 percent levy on Chinese goods — have sparked both alarm and opportunity among U.S. medtech manufacturers.
Under Pressure: Selecting the Right Pump for Cardiac Ablation Devices
A deep dive into cardiac ablation devices and the importance of selecting the right pump for such devices.
Exploring the Requirements for Reliable, High-Performing Elastomeric Medical Components
As medical devices become increasingly specialized and specific, the need for complementary componentry only grows. This critical, life-saving equipment depends on the ultimate in reliability and consistency, and device manufacturers must accept no compromises when sourcing items like latex or thermoplastic tubing, custom dip-molded parts, and more.
New Data Debunks Death Risk Warnings on Paclitaxel-Coated Devices
Based on a new meta-analysis on paclitaxel-coated devices, FDA updated guidance that eliminates the requirement for device manufacturers to include specific warning language within device labeling.
Plastic Gears Are Enabling Today’s Advanced Applications
Here’s what to consider, whether you’re converting from metal to plastic gears or designing gears for a novel device.
8 Advantages of Machining Your Metal Device
Machining metals is one of the best ways to ensure companies remain competitive in manufacturing.
