Medical Device


MDR and IVDR regulations
for Medical Devices

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

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

We provide conformity assessments for numerous standards related to medical devices’ 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 cybersecurity 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 unauthorized access to vulnerable personal data.

New Regulations on Medical Device Security

To learn more about the new standards, click below:




MDR Medical Devices
EU 2017/745



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

We offer instant advice and support to help you meet the Medical Device Security Standard


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


  • User guide Support and review of CyberSecurity design

Assessment Services for Medical Device Security

ISO 81001-5-1 - Health software and health IT systems safety

  • Development environment security assessment
  • Gap analysis
  • Risk assessment for the development environment
  • Threat modeling

Our complex Medical Device Security solution includes the following services

Gap analysis
Track progress in monthly reports
Preparation for certification
Track progress in monthly reports

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