Our Cyber Resilience Act (CRA) Services Include
CRA Readiness Assessment
We evaluate your product, software, and development processes against CRA cybersecurity requirements. This includes identifying gaps in security design, documentation, and lifecycle management.
Cybersecurity Risk Assessment and Threat Analysis
We support cyber risk assessments required under the CRA, ensuring that your product is designed to minimize vulnerabilities and attack surfaces before market entry.
Secure Software and System Development
We help implement secure-by-design and secure-by-default principles, ensuring cybersecurity is integrated into your product development lifecycle in line with CRA expectations.
Vulnerability Management and Reporting Processes
We design and implement processes for vulnerability handling, monitoring, and reporting, including compliance with mandatory reporting timelines for exploited vulnerabilities and incidents.
Technical Documentation and Compliance Support
We prepare and structure the required technical documentation, including cybersecurity documentation needed for CE marking under the CRA.
Lifecycle Management and Security Updates
We support the implementation of processes to ensure ongoing security maintenance, updates, and support periods, as required by the regulation.
Integration with Existing Regulatory Frameworks
For medical device companies, we align CRA compliance with MDR, IVDR, and IEC 62304, ensuring a unified regulatory strategy.
Strategic Value of CRA Compliance
Market Access in the EU
Compliance with the CRA will be a requirement for placing products with digital elements on the EU market. Non-compliant products cannot be sold after full enforcement in 2027.
Security Across the Entire Product Lifecycle
The CRA requires manufacturers to ensure cybersecurity from development through the full product lifecycle, including post-market activities.
Reduced Cybersecurity Risk
Implementing CRA requirements improves product security, reduces vulnerabilities, and strengthens trust with customers and stakeholders.
Improved Transparency and Trust
The regulation increases transparency around product security, making it easier for users and regulators to assess cybersecurity levels.
Alignment with Future Regulations
CRA compliance supports alignment with broader EU cybersecurity frameworks and standards, including NIS2 and other emerging requirements.
Regulatory-Ready Cybersecurity for Medical Devices and Software
to support full CRA compliance.
We ensure that your product meets both technical and regulatory requirements, including:
- Cybersecurity requirements integrated into product design and development
- Preparation of technical documentation for CE marking
- Alignment with medical device regulations (MDR/IVDR) where applicable
- Integration with software lifecycle standards such as IEC 62304
- Support for audits, conformity assessment, and market entry
This integrated approach ensures efficient compliance and reduces the risk of delays in market access.
Why Choose MDS Finland for CRA Compliance?
Combined Regulatory and Technical Expertise
We bridge the gap between cybersecurity requirements, software development, and regulatory compliance.
Experience with Medical and Software Products
Our team understands the specific challenges of medical device software and connected systems under evolving EU regulations.
Practical, Implementation-Focused Approach
We do not only interpret the regulation. We help you implement it in real development environments.
End-to-End Support
From initial assessment to technical documentation and market readiness, we support the full CRA compliance process.
Preparing for the Cyber Resilience Act
The Cyber Resilience Act represents a major shift in how cybersecurity is regulated in the EU. At MDS Finland, we help you move from understanding the requirements to implementing them in practice.
Our CRA services ensure that your products are secure, compliant, and ready for the European market.
