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Medical Cybersecurity

Implementing Cybersecurity for Medical Devices to Provide Excellent and Secure Patient Care

Medical Cybersecurity for a Secure Patient Care

The growth of digital innovation and its application into the healthcare industry has completely transformed the sector, bringing with it multiple improvements in efficiency but also several new threat scenarios. As medical devices rely on components, networks and software technology, enhancing cybersecurity for medical devices is critical to secure patient’s personal information in order to provide excellent and secure patient care. 
At DEKRA, we support our customers in navigating the complex landscape of medical cybersecurity, ensuring compliance with relevant standards and baseline cybersecurity requirements for medical devices before they enter international markets.. 

Safeguarding Health by Implementing Security by Design

DEKRA offers a comprehensive portfolio of medical cybersecurity services to lead organizations in complying with the international health regulations and standards while providing understanding of the importance of implementing security by design to enhance security along the medical device life cycle.
Medical Cybersecurity Trainings
Concept Evaluations
Medical Devices Penetration Testing

Medical Cybersecurity Certifications to Ensure Device Safety

As a leading expert in medical cybersecurity, DEKRA supports producers and manufacturers in navigating the requirements of the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) transition process in order to meet the requirements and receive the CE mark that allows medical devices to be sold in the European market. These new regulations bring enhanced security of medical devices in the European markets while increasing patient’s safety. The aim is to create a robust, secure and sustainable regulatory framework that safeguards clinical safety and establishes fair market access for producers and manufacturers.
    • Complying with MDR and IVDR regulations is crucial for medical device manufacturers as they introduce stricter safety requirements for all the health equipment incorporating electronic programmable systems and software.
    • MDR places more emphasis on the medical device lifecycle, prioritizing the implementation of a security risk management process and a secure by design approach.
    • The transition period for the MDR/IVDR has been extended, with the Medical Device Regulation (MDR) concluding on December 31st, and the In Vitro Diagnostic Device Regulation (IVDR) concluding on December 31st, 2030. From DEKRA, we recommend medical device manufacturers to address now the requirements of the new regulations to ensure the continued certification of their products while allowing time necessary time for any required product adjustment.

    Why DEKRA ?

    DEKRA supports medical device manufacturers to navigate their way through the complex landscape of regulatory requirements before selling the healthcare equipment's on international markets. We ensure that your products comply with the respective international standards and regulations, strengthening the cyber resilience of your medical devices to provide excellent and secure patient care.