The idea of pre-validated packaging sounds really good. Using packaging that has already undergone extensive testing seems ...

ISO 10993-7:2026 replaces table-based EO residual limits with a risk-based framework that requires manufacturers to justify ...

Discover why micro molding requires a complete manufacturing architecture integrating design, tooling, automation, metrology, ...

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 ...

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 ...

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 ...

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 ...

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 ...

The beauty devices business is booming. The global value of the cosmetic industry amounted to over $530 billion in 2022, with an expected growth rate of roughly 4% over the next five years, while the ...

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 ...

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 — ...

The National Security Agency (NSA) is interested in collecting information from biomedical devices for national security purposes, according to recent statements made by the agency’s deputy director, ...