Tag Archives: global regulatory strategy

AI Compliance in Medical Devices

Is Your Organization Ready to Govern AI in Regulatory Affairs?

By Geethapriya (Priya) Setty
AI Compliance in Medical Devices

By the time most medtech organizations noticed their teams were using AI in regulatory work, the governance conversation was already running behind.. How can your organization move forward? An Operational AI Capability Maturity Model — a five-domain framework built specifically for regulatory affairs and offers a direct way to assess where your organization actually stands. If your team cannot consistently answer who approved the tool, how the output was verified, and what was retained, this framework is a practical place to start.

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Veeva 2025 Regulatory Affairs Benchmark Report

2025 Medtech Regulatory Affairs Benchmark

Veeva 2025 Regulatory Affairs Benchmark Report

The 2025 Medtech Regulatory Affairs Benchmark reveals that many medtech companies lack confidence in their data’s completeness or accuracy and still rely heavily on manual processes to maintain compliance. This is largely underpinned by pervasive siloed processes, which make preparing regulatory submissions a resource-intensive endeavor.

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