Mass consolidation is sweeping up small medtech organizations. Med device startups and early-stage companies that want to be ...

Across Latin American medical device markets, the local authorized representative that holds or manages the regulatory asset ...

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

Periodically, standards are revisited by international and national committees to determine if they are still current or need revision or withdrawal. Through the voting process and based on comments ...

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 ...

Artificial intelligence (AI) and machine learning (ML) are redefining healthcare, from enabling earlier diagnoses and personalized treatments to streamlining hospital operations and accelerating ...

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, ...

This article is the first of a two-part series; read part two here. The U.S. Food and Drug Administration (FDA) is increasing demands [i],[ii] for drug delivery device developers to demonstrate the ...

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 ...

The wearable medical device industry sits at the intersection of life sciences regulation and rapidly-evolving technology law. Companies in this space face overlapping legal frameworks that can ...

When two or more people from the world of medical technology meet, talk inevitably turns to the ongoing, yet elusive, search for an industry-standard, multidisciplinary diagnostic device: the fabled ...