Policies & Regulations
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2017.01.18
Two Big Moves at FDA
FDA launched two major initiatives in 2016—cybersecurity requirements and a national system for real-world device monitoring.
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2017.01.10
Protecting Software as a Medical Device
Patent protections for Software as a Medical Device are increasingly important due to the additional investments in clinical evaluation that may be needed to withstand the FDA scrutiny under the new draft guidelines.
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