Explore how OEMs optimize instrument performance with precision fluidics, optical technologies, and integrated subsystems that improve reliability and accelerate development. Teams must assess the ...

A recent survey conducted with BioPhorum members revealed that the most critical aspect of digital healthcare for drug delivery devices. Let's take a closer look.

In 2023, the FDA made the electronic Submission Template And Resource (eSTAR) mandatory for most 510(k) submissions. Although eSTAR is not an AI tool, the move was the first definitive leap toward the ...

Device functionality testing is an essential element of any medical device or drug delivery device development process. It is an essential part of design verification that demonstrates the developed ...

An FDA warning letter is more than a formal notice; it’s a visible sign that a company’s quality system has failed to meet critical expectations. Yet behind every warning letter lies a wealth of ...

Product labels that appear on device packages, admittedly, are not the most exciting part of medical device product design and development. They lack the excitement of scientific discovery, the cachet ...

For years, manufacturers relied on a table-based approach to determine allowable ethylene oxide residual limits, an approach that didn't adequately account for vulnerable patient populations or device ...

Periodically, standards are revisited by international and national committees to determine if they are still current or need revision or withdrawal. Through the voting process and based on comments ...

Regulatory oversight and scrutiny of health technology (healthtech) companies has emerged as a priority for the federal government. Charged with mitigating fraud and abuse, protecting consumers, and ...

The FDA proposed on Feb. 22, 2022, an update to the Quality System Regulation 1 that was released in 1996. The proposal is to reference ISO 13485:2016 Medical devices — Quality management systems — ...

For years, Chile has occupied a strange position in Latin American medtech strategy. It was sophisticated, stable, commercially attractive, and comparatively easy to enter. For many medical device ...

FDA has now completed just over 100 inspections under its new Quality Management System Regulation, and the agency has begun sharing preliminary observations from those inspections. Early FDA findings ...