Post-Market

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....

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