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