Cybersecurity & data privacy for medical devices
Develop medical device software that meets the requirements of cybersecurity and data privacy for medical devices. We consider cybersecurity and data privacy top priorities, building them into the development process from day one.
Why do medical device companies work with us?
Cybersecurity and data privacy for medical devices addressed too late makes audit readiness harder to achieve and increases the risk of delays and redesigns.
Medical device companies work with us when they need software that is secure by design and ready for regulatory scrutiny without slowing down development. Cybersecurity, data privacy, and medical documentation security are embedded across the entire lifecycle, from requirements and threat modelling to secure coding, access control, and verification, ensuring full traceability and alignment with EU, UK, and U.S. expectations.
Common cybersecurity challenges in MedTech
Cybersecurity is treated as a late-stage phase, not an ongoing process
Balancing security requirements across standards: ISO 14971, ISO 27001, and MDR
Integrating separate concepts, such as patient safety vs cybersecurity
Ensuring patient data protection
Poor traceability between requirements, risks, and tests
Inadequate SOUP verification and management process
Lack of a structured approach to security requirements definition and threat modelling
Gaps between policy and practice within the organisation
Our cybersecurity approach
Security by design & security by default
Integrated risk management
Data privacy management
Compliance & secure coding practices
Threat modelling & testing
Documentation built into the process
Security in the organisation
Security by design & security by default
Lower audit risks, avoid costly rework, and support safe launch through Secure Software Development Lifecycle (SSDLC) built into your platform from the start.
We apply a secure baseline across architecture, infrastructure, and development practices, including encrypted communication, network segmentation, and protection against common threats (e.g., OWASP top 10). For cloud-based systems, we design infrastructure structured into controlled subnets, improving resilience and minimising the impact of potential breaches.
Integrated risk management
Reduce regulatory risk and eliminate gaps between safety and cybersecurity, and medical data protection, ensuring your software remains reliable and audit-ready.
We conduct risk analysis in line with ISO 14971, aligning safety and security considerations, maintaining full traceability, and supporting continuous risk evaluation throughout the software lifecycle.
Data privacy management
Protect sensitive data and minimise the risk of security incidents across your system, including electronic medical records security.
Our practices align with ISO 27001. We implement data privacy measures, including data anonymisation and pseudonymisation, assess security using the CIA triad (confidentiality, integrity, availability), define data ownership, and classify data while ensuring compliance with GDPR or HIPAA.
Compliance & secure coding practices
Ensure compliance with global data protection and security standards, and EU MDR cybersecurity requirements without slowing down development or increasing audit complexity.
Our practices are aligned with MDCG 2019-16 (MDR), ISO 27001 (ISMS-11A-PR1), GDPR, and HIPAA and based on recognised frameworks such as OWASP and the NIST Cybersecurity Framework to support threat identification and the selection of appropriate security measures.
Threat modelling & testing
Identify and mitigate high-risk threats early, before they impact your product or delay your launch.
Based on the system architecture and design specifications, we conduct structured threat modelling, including the identification of trust boundaries and analysis using the STRIDE methodology (OWASP).
Documentation built into the process
Stay fully prepared for audits with complete, structured, and traceable documentation.
We maintain documentation in Confluence and Jira, ensuring end-to-end traceability by linking all elements (e.g., risks, tests) and systematically documenting external components (e.g., SOUP) where applicable.
Security in the organisation
We embed cybersecurity across the entire organisation to ensure your assets are protected both within and beyond the project scope, with particular focus on security of records.
We secure infrastructure, protect entrusted devices, and enforce strict access controls to documentation and code repositories (e.g., Git), including mandatory device encryption and multi-factor authentication (MFA).
Discuss cybersecurity & data privacy before they become a risk
Schedule a meeting with our team to identify gaps, reduce audit pressure, and ensure your software is secure by design from the start.
What this means for your project with us
Cybersecurity is built into your process from day one
No late-stage cybersecurity redesigns driven by security gaps
Reduced audit-related risks
Full traceability between risks, controls, and implementation
Continuous risk management across the product lifecycle
Controlled use of third-party components (SOUP) to reduce hidden risks
Data privacy aligned with GDPR, HIPAA, and ISO 27001
Case studies
See how our approach works in real projects:
How do we work within your responsibility model?
We work as a critical software supplier within your quality and regulatory framework, while you remain the legal manufacturer responsible for the device. This supports audit readiness, maintains clear ownership, and reduces the risk of gaps between software development and compliance.
We integrate cybersecurity, data privacy, and healthcare data protection into every stage of development, adapting them to the context of your device, architecture, and regulatory requirements, ensuring systems that are secure by design, compliant with regulations, and trusted by users.
About Revolve Healthcare
We design and develop secure medical software, applying best practices in medical device cybersecurity to protect sensitive health data, support clinical workflows, and integrate with connected devices and digital ecosystems.
Cybersecurity and data privacy are built into our development process from day one. We operate within an ISO 13485-certified QMS and use our Agile 62304 framework to align Agile delivery with IEC 62304, ISO 27001, ISO 14971, and IEC 62366.
We have contributed to more than ten MDR- and IVDR-aligned software projects, covering platform development and legacy code refactoring.
Discuss your software architecture, cybersecurity risks and certification challenges with our experts
During the 45-minute session you will:
clarify your software scope
identify potential cybersecurity and data protection risks
understand regulatory expectations for your project
get direct answers to your specific questions.