Insights

News, updates, and meaningful insights from the MBK Search team.

LATEST INSIGHTS
18 September 2023
10 things to know about the FDA's new Voluntary Improvement Program
The FDA recently released guidance detailing a new Voluntary Improvement Program that utilizes third-party appraisals to assess and enhance medical device manufacturers' practices.
28 August 2023
Why the UK & EU have different plans to regulate med-tech AI
The UK government and the European Medicines Agency have both published draft roadmaps to regulate the use of AI in the medical technology industry. In this edition of The GRC Story, we explore the key similarities and differences in plans, and what they’re hoping to achieve.
14 August 2023
Should the FDA crack down on custom device promos?
Is it time the FDA clamped down on the way custom-devices are promoted online? We look at the issue in detail in this week's edition of The GRC Story
1 June 2023
The FDA is being outrun by AI. Here's how it can keep up
As the FDA in the U.S. admits the agency cannot keep pace with new technologies in health care, questions are being asked about what it can do to keep pace.
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