For complex medical device systems, teams must define what must happen across subsystem boundaries, assign responsibility for ...

On Sept. 16, 2026, the International Organization for Standardization (ISO) published the sixth edition of ISO 9001. Most medical device professionals shrugged. We live in ISO 13485. We answer to the ...

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 ...

European Medical Device regulations define “benefit-risk determination” as "the analysis of all assessments of benefit and risk of possible relevance for the use of the device for the intended purpose ...

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 — ...

Most parenteral packaging components require surface treatment or lubrication to ensure they work smoothly. Silicone oil has traditionally been used for this purpose – and is still regarded as an ...

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 ...

Surgical navigation and robotic systems are not novel technologies and have had a historical presence since the 19th century. Surgical navigation is a result of evolution from a frame-based stereotaxy ...

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 ...