CDRH and CBER Release Final Guidance for the Q-Submission Program and Draft Guidance for PreSTAR - On May 29, 2025, the U.S. Food ...

In this episode of Denatured, presented by IQVIA, BioSpace’s head of insights Lori Ellis discusses how AI transformation can ...

FDA staffers in the Center for Devices and Radiological Health told NBC News that their AI pilot, CDRH-GPT, is buggy, isn't ...

A new FDA artificial intelligence tool designed to streamline medical device reviews is faltering in its early rollout stages, raising concerns for agency staff and ethics experts about its ...

SCOTTSDALE, AZ, UNITED STATES, June 3, 2025 /EINPresswire.com/ -- Blue Goat Cyber, a leading authority in medical device cybersecurity and FDA compliance strategy, proudly announces its sponsorship of ...

However, the integration of AI into medical devices raises significant regulatory challenges. Ensuring that these ...

Regulatory agencies such as the FDA and EMA, as well as many others, set stringent guidelines for safety labeling. These guidelines are designed to ensure that safety information is communicated ...

Beyond recommendations for information and documentation to support marketing submissions, the draft guidance provides recommendations for design, development, deployment, and maintenance of ...

The medical device industry faces increasing regulatory complexity, leading to long delays in registration and market entry. These timelines not only slow patient access to life-saving devices but ...

In the evolving landscape of medical device regulation, understanding and complying ... documentation for EU and global submissions (FDA, Health Canada, TGA, Russia, Latin America).

The "The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation) Training Course" training has been added to ...