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 — ...

In medical device development, document approvals seem to always be a roadblock when you are the most pressed for time. How much time do you have to take to explain the change to an approver? What ...

Imagine a fire sweeping through a forest. It moves quickly, burns through almost everything in its path, produces immense destruction, and changes entire landscapes. It also clears out dead debris and ...

The most expensive decision a U.S. medical device company makes in Latin America is rarely the one its leadership team has on the agenda. It is not the choice of country. It is not the product ...

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 ...

In micro molding, automation is far more than robotics on the factory floor—it is the manufacturing architecture that enables quality, scalability, and repeatability. While conventional molding ...

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, ...

As vascular procedures grow more complex, low-pressure balloons are increasingly relied on for tasks that demand flexibility rather than force. These compliant structures are designed to conform to ...

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 ...