Proactive cybersecurity solutions for a connected future of medical devices

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.

Strength through strategy
and transformation

With deep expertise in cybersecurity, Sunrise Labs addresses the unique challenges of protecting sensitive data, systems, and medical devices across various industries.

We don’t stop at identifying vulnerabilities or implementing safeguards. We are your partner through the entire lifecycle of your cybersecurity solution, ensuring robust protection every step of the way.

Explore deeper insights on Cybersecurity

Check out our in-depth webinar recordings and articles to better understand our approach to cybersecurity for medical product development