Cybersecurity | IT security for medical devices and processes
As medical devices become increasingly connected, the risk of cyber-attacks, manipulation and data leaks is growing. Effective IT security is essential for ensuring long-term patient and product safety and compliance.
We support you with all IT security matters, from analysis to implementation. We review the legal and normative requirements that apply to you, ensuring that they are implemented in a compliant and audit-proof manner.
Overview of our services:
- Analysis of relevant requirements according to the MDR and the NIS-2
- Review of processes and technical documentation for completeness and compliance
- Conducting a GAP analysis and providing clear recommendations and advice
- Risk assessments for systems according to STRIDE (preferably with NIST CVSS)
- Integrating cyber security into the product lifecycle in accordance with IEC 81001-5-1 or FDA cybersecurity guidelines
- Review of the integration of ISO 27001 and BSI IT-Grundschutz requirements into your processes (including GAP analysis)
- Workshops on topics such as the integration of cloud service providers or compliance with the GDPR
Consulting and Analysis
We provide expert advice on all cybersecurity matters within the regulated pharmaceutical and medical technology sectors - from IT infrastructure and processes to the specific safety requirements of medical devices..
Our approach:
- Conducting stakeholder interviews
- Using checklists and gap analyses to identify vulnerabilities
- Providing actionable, pragmatic recommendations
- Reviewing and evaluating existing documentation
Risk Analysis and Risk Assessment
In the development of software-based medical devices, we provide tailored security risk assessments, including:
- Mapping assets and interfaces to associated risks
- Conducting threat modeling using the STRIDE framework
- Developing comprehensive risk matrices
- Assessing severities in line with NIST CVSS standards
- Defining concrete and effective mitigation actions
Implementation measures
We support you in prioritizing and implementing identified recommendations or your own security initiatives. This is crucial to address critical risks early, ensure compliance and safeguard both patient safety and process stability.
Our services include:
- Development of templates and processes
- Comprehensive process documentation
- Seamless integration into your QMS and workflows
- Ensuring NIS-2 compliance
