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Cybersecurity in medical device development refers to the practices and processes implemented to protect medical devices, patient data, and healthcare systems from cyberattacks. As medical devices become increasingly interconnected and collect more patient data, the need for robust cybersecurity measures becomes critical.
While the FDA outlines cybersecurity requirements in its pre-market guidance, mandating device manufacturers assess cybersecurity risks before 510(k) or PMA submission, it does not mandate all of the methodologies to achieve the requirements. In this manner, firms can customize their approach based on their specific contexts. The absence of a standardized approach, however, means that insufficient approaches may lead to undiscovered vulnerabilities and potential cyber-attacks.