On Sept. 16, 2026, ISO published the sixth edition of ISO 9001. Most medical device professionals shrugged, feeling that we ...

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.

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 — ...

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 ...

Cardiovascular diseases are responsible for over 15 million deaths worldwide per year. 1 The occlusion of vessels such as the coronary or peripheral arteries hinders the flow of blood to the heart, ...

On the surface, unique device identification (UDI) is a simple concept. Put the device identifier (DI) on the device label in machine‑readable form. Include the production identifiers (PI) that you ...

SCS devices deliver electrical pulses to the spinal cord to relieve chronic pain. They are often used as treatment for failed back surgery syndrome, injuries to the spinal cord, complex regional pain ...

The amount of environmental control, environmental monitoring, and finished product testing necessary to ensure medicinal product microbiological safety and product quality depends on factors such as ...

Most medical device designers and developers have some familiarity with the Q-Submission Program of the FDA. Relatively few, though, know how to best use the program to effectively speed the product ...

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 ...

Part 1 of this series presented factors that medical device developers should consider when executing HFE studies internally, detailing how to overcome obstacles while acknowledging that executing ...