Advances in stretchable electronics and on-device intelligence are transforming wearable healthcare, enabling continuous ...

India’s Ministry of Health and Family Welfare has proposed amendments to the Medical Devices Rules 2017 that will shorten ...

In June, Brazils ANVISA released a batch of clinical trial petitions because its review deadline had expired without a ...

The #1 QMS In Life Sciences Puts You in Complete Control MasterControl Quality Excellence is trusted by 1,100+ customers — from startups to global enterprises — to bring quality products to market ...

In micro medical manufacturing, a prototype that fits perfectly in the lab can still fail at production scale. When device performance depends on leak-tight seals, precise dosing, fluid flow, or ...

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 ...

Across industries, innovation platforms constantly monitor device usage and anticipate future needs, fueling breakthrough ideas in real time. AI agents are dissolving silos in large organizations, ...

High-purity PFA tubing is engineered to meet the rigorous demands of precision fluid handling applications where reliability, cleanliness, and performance are critical. Manufactured from PFA ...

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 ...

Within the EU's regulations, Article 10(9) refers to quality system requirements under Annex IX. This is a specific requirement concerning quality control for the devices that use AI technology under ...

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 ...