Navigating Cybersecurity and Software Testing Requirements for Regulatory Submissions in the U.S., EU, Canada, and the UK

Globally, cybersecurity, software requirements, and testing for software-related medical device submissions have become critical components of regulatory submissions. As connected medical devices proliferate and software becomes increasingly embedded in product functionality, regulators across the U.S., European Union, Canada, and the UK have raised the bar on third-party testing and monitoring expectations.

United States (FDA)

The U.S. Food and Drug Administration (FDA) has made cybersecurity a priority for software-related medical device regulatory submissions—particularly for 510(k), De Novo, and PMA pathways.

Key Requirements:

• Premarket Cybersecurity Guidance (Final, 2025): Manufacturers must provide detailed documentation on their device’s cybersecurity risk management, architecture, threat modeling, vulnerability testing, and software lifecycle controls.
• Software Bill of Materials (SBOM): Devices that contain software (including off-the-shelf or open-source components) must include an SBOM to enhance transparency and vulnerability management.
• Third-Party Penetration and Vulnerability Testing: The FDA expects robust, independent testing of device cybersecurity defenses—preferably conducted by qualified third parties—covering both static and dynamic analysis, penetration testing, fuzz testing, and more.
• Postmarket Surveillance & Monitoring: A cybersecurity plan must be submitted, detailing how manufacturers will monitor, identify, and remediate vulnerabilities throughout the product lifecycle.
• Quality System Consideration: Cybersecurity concerns/controls must be integrated within your design control/risk management processes, as well as, your post market surveillance processes. The records created will directly support your premarket submission success.

European Union (EU)

Under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), the EU has placed strong emphasis on cybersecurity as part of General Safety and Performance Requirements (GSPR).

Key Requirements:

• Annex I of MDR/IVDR: Requires device manufacturers to address cybersecurity within their risk management, design validation, and post-market surveillance activities.
• Harmonized Standards & MDCG Guidance: Standards such as EN IEC 62304, EN ISO 14971, and MDCG 2019-16 guide software lifecycle processes and cybersecurity practices.
• Third-Party Testing & Clinical Evaluation Support: While explicit third-party testing is not mandated, Notified Bodies increasingly expect independent validation of cybersecurity controls, especially for network-connected or high-risk devices.
• Technical Documentation: Must include results of software verification, validation, and any security testing, often supported by independent assessments or audits.

Canada (Health Canada)

Health Canada regulates software and cybersecurity under its Medical Devices Regulations, especially for devices classified as Class II and above.

Key Requirements:

• Guidance for Software as a Medical Device (SaMD): Emphasizes software validation, risk control, and change management processes. Cybersecurity risks must be assessed and mitigated.
• Security Testing and Validation: Third-party testing is not formally required but highly recommended for network-enabled devices. Supporting evidence from independent validation can expedite reviews.
• Documentation Expectations: Submissions must demonstrate compliance with IEC 62304, ISO 14971, and relevant portions of IEC 60601-1 (where applicable), including cybersecurity verification.

United Kingdom (MHRA)

Post-Brexit, the Medicines and Healthcare products Regulatory Agency (MHRA) has closely aligned with the EU while developing its own regulatory framework.

Key Requirements:

• Software and AI Guidance (2023): MHRA outlines expectations for secure-by-design principles, software lifecycle controls, and cybersecurity threat mitigation.
• UKCA Marking: Requires compliance with standards such as BS EN 62304, BS EN ISO 14971, and newer cybersecurity-specific guidance—especially for AI/ML and connected devices.
• Third-Party Testing Expectations: MHRA recognizes the value of independent cybersecurity testing and monitoring and will increasingly expect manufacturers to demonstrate external validation of security measures during conformity assessments.

Why Third-Party Cybersecurity & Software Testing Matters

Across all four jurisdictions, regulatory bodies are converging on a common theme: cybersecurity cannot be an afterthought. Independent testing—whether for software performance, vulnerability exposure, or risk management—is rapidly becoming an industry best practice and, in many cases, a de facto requirement.

At RQMIS, we’ve built a strong capability in Cybersecurity and Software Testing & Monitoring, with experience that spans both commercial and government sectors—including a recent project for the U.S. Army, where our Cybersecurity and Software Development teams collaborated to build a resilient, secure platform under stringent defense-grade requirements.

We offer:

• Cybersecurity risk assessment and threat modeling
• Penetration and vulnerability testing (static, dynamic, fuzz)
• SBOM creation and validation
• Software verification/validation aligned to IEC 62304
• Ongoing monitoring and postmarket surveillance support

Ready to Ensure Compliance and Peace of Mind?

If you're preparing a regulatory submission in the U.S., EU, Canada, or UK—and your device includes software or connectivity—now is the time to invest in robust cybersecurity and software testing. Let us help you reduce risk, accelerate approval, and protect patients.