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

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

As technical demands continue accelerating across life sciences, pharmaceuticals, and aerospace, organizations are increasingly recognizing that innovation cannot happen in isolation. A recent Forbes ...

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 ...

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 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 — ...

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 ...

One common source of misunderstanding in the medical device industry is the method the various national regulatory systems use to identify standards. This article explains the method, starting with ...

We are close to a new era in ultrasound technology. From helping healthcare specialists detect several diseases such as cancerous cells to showing real-time images inside the mother’s womb, ultrasound ...

Raising funds in the medical device industry is always challenging. Doing so as a startup can be even more so. And U.S. medical device companies seeking funding this year will find that innovative ...

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 objective of the Batteries Directive is to minimize the negative impact of batteries and their hazardous components on the environment through the approximation of EU member countries’ legislation ...