Medical devices

Cybersecurity evaluation

Active and IVD devices which are connected, store any data, include any computing, control analog or digital functionality are subject to mandatory assessment and validation of cyber security risk. We execute cybersecurity evaluations based on the strictest accreditations and standards.


Cybersecurity consulting

Standard, legislation, guidance


AAMI TIR57 Prepare / support the Risk Management File based on Cybersecurity
AAMI TIR57 Provide expert review of the acceptability of all residual risks for Cybersecurity
- Monitoring the state-of-the-art level of Cybersecurity and reporting regularly
MDR I. Support and review the Information for Use based on Cybersecurity

EN 60601-1

EN 62304

IEC 82304-1

EN 62304

Change or create design and development procedures for Cyber Security

EN 62304

(IEC 62304)

Evaluation of Cyber Security aspects of software requirements:

• software architecture security analysis

• safety review of risk analysis

IEC/TR 60601-4-5

(IEC 62443-4-2)

Safety aspects of medical devices, support for safety level classification

ISO/IEC 27001

ISO/IEC 27002

Development and certification support of Information Security Management System


Cybersecurity testing

Standard, legislation, guidance


EN 62366-1 Formative evaluation (expert review, standard review)
EN 62336-1 Summative evaluation (Usability test)