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Medical Device Security

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Medical Device Security

Medical devices have been around for decades, however new technologies are being applied to all different types of them.

It is a challenging task to secure devices against cyber threats while the clients expect to preserve functionality without overcomplicated security measures.


The software usually connects to the internet or hospital networks, the data can be available through mobile phones or other connected devices.

We provide conformity assessments for numerous standards related to the medical device’s cybersecurity resilience


Among many novelties linked to cybersecurity risks, two new Regulations on medical devices have been adopted and entered into force on 25 May 2017. 

These regulations introduce new essential safety requirements for all medical devices that incorporate electronic programmable systems and software that are medical devices in themselves within the EU.

This means that manufacturers have to develop and manufacture their products in accordance with the state of the art technologies and taking into account the principles of risk management.

The above affects information security, as well as requires to set out minimum requirements concerning IT security measures, including protection against unauthorised access to vulnerable personal data. 


To learn more about the new standards, click below:

MDR 745/2017 - MDR Medical Devices Regulation; EU 2017/745

IVDR 746/2017 - IVDR In Vitro Diagnostic Medical Devices Regulation; EU 2017/746


We can advise you instantly and support you to prepare and meet the following standards


  • AAMI TIR57 - Principles for Medical Device Security - Risk Management
    • Creation and support of Risk Management files according to CyberSecurity
    • Provide expert opinion on the acceptability of all remaining risks for CyberSecurity
  • ISO/IEC 27001, ISO/IEC 27002 - INFORMATION SECURITY MANAGEMENT and Security techniques
    • Implementation of information security management systems and certification support
  • IEC/TR 60601-4-5 (IEC 62443-4-2) -
    Support of security level specification and determination of the safety aspects of medical devices
  • EN 62304 (IEC 62304) - Medical device software life cycle processes
    • Evaluation of medical device software requirements
    • safety assessment of software architecture
    • safety review of risk analysis


  • EN 60601-1 and EN 62304, IEC 82304-1 and EN 62304
    • Transformation or creation of design and development procedures for CyberSecurity
  • MDR I.  
    • User guide Support and review of CyberSecurity design


  • ISO 81001-5-1 - Health software and health IT systems safety
    • Threat mitigation testing
    • Secure requirements testing
    • Threat modeling


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