Cybersecurity for life sciences and IVD medical devices
Protecting your intellectual property and digital assets from cyber threats
Confidentiality
Ensuring that data is not available or disclosed to unauthorized individuals, entities, or processes
Integrity
Maintaining data consistency, accuracy, and trustworthiness throughout its entire lifecycle
Availability
Ensuring that data is consistently and readily accessible for authorized individuals, entities, or processes
Secure-by-design approach for life sciences and medical device software
We design software with key security properties—confidentiality, integrity, and availability—to provide life sciences companies with a competitive advantage. Our secure-by-design approach starts at the beginning of the development lifecycle, incorporating high-level practices like code reviews, static analysis, and penetration testing.
We implement input validation and sanitization, continuously monitor threats and vulnerabilities, and apply updates promptly. We ensure data confidentiality through data encryption, access management and access controls, verify integrity of data with digital signatures and audit trails, and guarantee availability through redundancy, failover, and protection against denial-of-service attacks.
To protect supply chains from disruptions, we also implement backup mechanisms and devise a disaster recovery plan to ensure data can be restored. Risk assessments are conducted regularly to prevent data breaches and vulnerabilities.
Thorough cybersecurity services for secure operations
Our cybersecurity services for life sciences companies include:
Threat modeling and prioritizing security solutions
We develop a threat model based on risk analysis and help you keep up with the latest developments in the ever-changing security landscape. We also provide security assessments and analyses of existing systems to identify vulnerabilities and prevent potential non-compliance with industry regulations, including those affecting your supply chain.
Security testing
We provide thorough penetration testing and/or vulnerability assessments via a trusted third-party partner to safeguard against potential cyber attacks and phishing emails, and vulnerabilities in your data management systems that could lead to a data breach.
Cybersecurity features
Standards and regulations such as IVDR and 21 CFR Part 11 require software features that support cybersecurity. We have successfully implemented features like audit trail and access control (user authentication, authorization with user management) that have enhanced cybersecurity framework and satisfied regulatory requirements, including those for pharmaceutical companies.
Three pillars of cybersecurity strategies
Confidentiality
Confidentiality means sensitive information is accessible only to those authorized to view it. In the context of life sciences and IVD software, this often includes patient data, proprietary research, and other sensitive information.
Breaches of confidentiality can lead to severe consequences, including loss of trust, legal repercussions, and significant financial losses.
How to safeguard confidentiality
✔ Encrypt Data: Utilize standardized cryptographic algorithms to encrypt data both at rest and in transit. This ensures that even if data is intercepted, it remains unreadable to unauthorized parties.
✔ Implement Access Controls: Restrict access to sensitive data through robust access control mechanisms. Only authorized users and processes can access critical information, reducing the risk of unauthorized exposure and data breaches.
Integrity
Integrity is about maintaining the accuracy and trustworthiness of data and software. Any alteration, whether malicious or accidental, can have dire consequences, especially in fields like diagnostics, where precision is paramount.
Best practices to maintain integrity and enhance cyber security
✔ Digital Signatures and Message Authentication: Employ digital signatures and message authentication codes to verify that data and software have not been tampered with. This ensures that any modifications are detectable.
✔ Integrity Checks and Audit Trails: Implement regular integrity checks and maintain detailed audit trails. These help not only in detecting data breach caused by a cyber attack but also in tracing their origins for a more accurate risk assessment.
✔ Backup and Disaster Recovery Plans:Regularly back up data and develop comprehensive disaster recovery plans. This ensures that data can be restored to its original state in the event of corruption or loss.
Availability
Availability ensures that systems and data are accessible when needed. In the life sciences and IVD sectors, downtime can disrupt critical processes, leading to delays in diagnostics and research.
How to ensure availability
✔ Design for Failure:Implement redundancy, failover, and load-balancing mechanisms. These measures ensure that even if one component fails, others can take over, maintaining system functionality.
✔ Protect Against Denial-of-Service Attacks: Use techniques like rate limiting, whitelisting, and traffic filtering to guard against denial-of-service attacks that can cripple systems.
✔ Backup and Recovery: As with integrity, maintaining regular backups and a solid disaster recovery plan is crucial to restore functionality swiftly after disruptions, including ransomware cyber attacks.
Explore our projects
Frequently asked questions (FAQs)
What is cybersecurity for medical device and laboratory software?
For medical device, IVD, laboratory, and pharmaceutical software, cybersecurity should be considered throughout the software lifecycle: from architecture and development to deployment, vulnerability management, security updates, and maintenance.
What are the main cybersecurity risks for laboratory and medical software?
Medical device and laboratory software often process sensitive data, support critical workflows, and communicate with connected instruments and external systems.
Common risks include unauthorized access, insecure APIs and communication interfaces, vulnerable third-party components, insufficient access controls, insecure data storage or transfer, and unpatched vulnerabilities.
Connected instruments and integrations can also increase the attack surface. Depending on the system, a cybersecurity incident could compromise sensitive data, affect data integrity, disrupt laboratory operations, or – in medical applications – create a potential patient safety risk.
Building cybersecurity into the software from the beginning helps reduce these risks while supporting long-term reliability and applicable cybersecurity and regulatory requirements.
Can you assess the cybersecurity of our existing software?
Yes. We can review your software architecture, code, dependencies, interfaces, and development practices to identify potential security risks and recommend practical improvements.
Depending on the project, we assess areas such as authentication, authorization, secure communication, data protection, dependency management, vulnerability management, and alignment with applicable cybersecurity requirements.
Which cybersecurity regulations and standards apply to our software?
It depends on the type of product, its intended use, and the market where it will be placed.
In the EU, the Cyber Resilience Act (CRA) introduces cybersecurity requirements for products with digital elements within its scope. Medical devices and IVDs covered by the MDR or IVDR are excluded from the CRA and follow their sector-specific regulatory requirements.
In the US, certain medical devices defined as “cyber devices” are subject to cybersecurity requirements under FD&C Act § 524B, together with applicable FDA requirements and guidance.
Relevant standards also depend on the product. IEC 81001-5-1 addresses security activities throughout the lifecycle of health software, while IEC 62443-4-1 may be relevant to products developed for industrial automation and control environments.
We help determine which cybersecurity requirements apply to your software and translate them into practical development and maintenance activities.
How can a medical device and laboratory software be protected from cyberattacks?
Protection starts with secure-by-design software development. This includes secure architecture, strong authentication and access controls, encryption, secure communication, dependency management, security testing, vulnerability management, and timely security updates.
Cybersecurity does not end when the software is released. New vulnerabilities can emerge throughout the product lifecycle, so monitoring, vulnerability assessment, patching, and controlled software maintenance are also important.
What is secure-by-design software development?
Secure-by-design means considering cybersecurity from the beginning of software development rather than adding security controls only before release.
It includes identifying security risks during requirements and architecture design, applying secure coding practices, managing third-party components and dependencies, testing security controls, addressing vulnerabilities, and planning how security updates will be handled after release.
This approach is increasingly reflected in cybersecurity requirements such as the EU Cyber Resilience Act and cybersecurity expectations for medical devices.
Can you improve the cybersecurity of existing or legacy software?
Yes. Cybersecurity can often be improved without rebuilding the entire application.
We can assess existing or legacy software, identify vulnerabilities and outdated components, and recommend or implement improvements to areas such as authentication, access control, communication, data protection, dependency management, and software architecture.
We can also help establish a process for ongoing vulnerability management and security updates.
Do we need to provide security updates after the software is released?
Yes, for some products this is a regulatory requirement. For products within the scope of the EU Cyber Resilience Act, manufacturers have obligations related to vulnerability handling and security updates during the defined support period. Medical devices and IVDs covered by MDR/IVDR are excluded from the CRA but have their own lifecycle and cybersecurity requirements.
In the US, manufacturers of medical devices that meet the definition of a cyber device under FD&C Act § 524B also have specific post-market cybersecurity obligations.
Even where a specific regulation does not mandate an update period, maintaining security updates is an important part of protecting long-lived software against newly discovered vulnerabilities.
Comprehensive software development services
We support your software development project at every stage, from software documentation to UX design and cybersecurity, along with many other services, helping you bring your product to market faster.
