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Is Your Phone App a Medical Device?
📢 DDReg Knowledge Capsule – Episode [1]
In this episode of the DDReg Knowledge Capsule, we dive into the evolving landscape of Software as a Medical Device (SaMD) — a transformative area in digital health that's reshaping patient care and healthcare delivery.
Join us as we explore:
🔹 What qualifies as SaMD under global regulatory frameworks
🔹 Key regulatory guidelines from the FDA, EU MDR, and IMDRF
🔹 Challenges in compliance, risk classification, and cybersecurity
🔹 Real-world examples of SaMD in diagnostics, monitoring, and therapeutics
🔹 How manufacturers can navigate regulatory pathways…
The skinny
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