Addressing security for the lifecycle of medical devices and software

Medical devices are connected to patients, care providers, and organizations big and small. Protecting that ecosystem is critical for everyone involved. We have experience with start-ups and global enterprises testing all types of smart medical devices including SaMD, clinical equipment, and wearables.

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Layer 8 Security can help with all regulatory cybersecurity testing requirements. We’ll ensure that your tests are complete and reportable to the FDA so your device and/or software gets approved with the first submission, whether it’s a PMA, 510(k), or DeNovo.

Other services we provide in this realm are ISO 27001 readiness & certification, NIST assessments, and Information Security Program Management to bring a holistic approach to the organization in its entirety, not just the device.

Learn more about our multifaceted approach, including:

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