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Understanding the FDA's Requirements for Pentests in Medical Devices

Learn how the FDA mandates penetration testing (pentests) for medical devices to ensure cybersecurity and patient safety. Discover key requirements, methodologies, and the role of pentests in premarket submissions. Fenrir.pro offers expert guidance for FDA and CE certifications. Contact us for cybersecurity solutions tailored to medical devices....

Understanding the CE Certification Requirements for Medical Devices

With the increasing connectivity of medical devices, cybersecurity has become a critical component of CE certification. The EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) emphasize the need for robust cybersecurity measures to protect patient safety and data integrity. Penetration testing (pentests) is a key tool in demonstrating that a device meets these requirements....