Medical Device
Security
however new technologies are
being applied to all different types of them.
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.
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MDR
MDR Medical Devices
EU 2017/745
IVDR
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 / IVDR
User guide Support and review of CyberSecurity design
Assessment Services
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 solution includes
the following services
Gap analysis
Risk assessment
Preparation for certification
