SOP Cybersecurity
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Use this SOP Cybersecurity template to establish and document your processes for identifying, mitigating, and managing cybersecurity risks in Software as a Medical Device (SaMD) and Software in a Medical Device (SimD) throughout their lifecycle, as required by regulatory standards. Complete this SOP during the design, development, premarket submission, and postmarket surveillance phases to ensure compliance with FDA, EU MDR, or IVDR cybersecurity requirements and industry best practices, thereby safeguarding patient safety and device functionality.