Medtech regulation shifts reshaping medtech strategy under new FDA rules
Medtech regulation shifts: Learn how to navigate new FDA changes on wearables, CDS, AI tools, and QMS, and realign strategy, risk, and compliance frameworks.
Category: Med-Device Compliance
Medical Device labeling revolution reshaping medical device safety
Explore how medical device labeling, UDI, and EU/FDA regulations enhance safety, traceability, and compliance while guiding practical risk and quality management.
Regulation Roadblocks Cloud AI Integration in Real‑World Evidence
Learn how AI integration in real-world evidence demands high-quality data, robust governance, and regulatory compliance to ensure trustworthy, regulator-ready insights.
Cyber Resilience Act deadline 2027 looming over unprepared manufacturers
In-depth analysis of the EU Cyber Resilience Act deadline in 2027, its 2026 reporting duties, and what manufacturers must implement now to keep products on the EU market.
FDA Mental Health Chatbot Rules Tighten Amid Rising AI Risks and Hype
The FDA’s announcement, published in the Federal Register, highlights the “novel risks” posed by devices having Mental Health Chatbots and signals a shift toward more stringent oversight to ensure safety and efficacy. This article explores the implications of these regulatory developments, the evolving landscape, and what it means for companies and users alike.