Medical Device Security Testing & VA/PT for FDA 510(k) Compliance | Cyber Risk Experts in Canada

Overview

Medical device manufacturers operating in or exporting to Canada must ensure their devices meet FDA 510(k) cybersecurity requirements. With connected and software-driven medical devices becoming more prevalent, Vulnerability Assessment and Penetration Testing (VA/PT) is critical to protect patient safety, maintain regulatory compliance, and mitigate cyber risks.

Cyberintelsys is a CREST-accredited cybersecurity company providing comprehensive Medical Device Security Testing and VA/PT services for FDA 510(k) compliance in Canada. Our services help manufacturers identify vulnerabilities, assess risks, and produce regulator-ready documentation.

Why VA/PT is Essential for FDA 510(k) Compliance in Canada?

Key benefits of VA/PT for medical devices:

  • Regulatory compliance: Meet FDA 510(k) cybersecurity guidance for premarket documentation.

  • Patient safety assurance: Detect and remediate vulnerabilities that could affect device functionality or patient outcomes.

  • Risk reduction: Prevent cybersecurity incidents that may result in recalls, fines, or market withdrawals.

  • Reputation management: Build trust with healthcare providers, regulators, and patients.

Engaging a CREST-accredited provider like Cyberintelsys ensures ethical, repeatable, and globally recognized testing practices.

Cyberintelsys Medical Device Security Testing & VA/PT Approach

1. Scoping & Asset Identification

  • Inventory of hardware, firmware, and software components

  • Mapping of network interfaces, wireless protocols, APIs, and cloud connectivity

  • Review of mobile applications and companion software

Deliverables: Detailed testing scope and device asset inventory.

2. Vulnerability Assessment (VA)

  • Automated vulnerability scanning with tools like Nessus and OpenVAS

  • Manual review of firmware, configurations, authentication, and encryption

  • Third-party library and dependency analysis

Output: Risk-ranked VA report with CVSS scoring and remediation guidance.

3. Penetration Testing (PT)

  • Network penetration testing of internal and external surfaces

  • Device exploitation to demonstrate potential real-world impacts

  • Wireless security testing (Wi-Fi, Bluetooth, IoMT protocols)

  • Mobile application, API, and cloud platform testing

Deliverable: Proof-of-concept testing reports aligned with FDA 510(k) submission requirements.

4. Risk Analysis & Prioritization

Prioritize vulnerabilities based on exploitability, regulatory impact, and patient safety consequences.

5. Reporting & Compliance Documentation

  • CREST-aligned reports for FDA 510(k) submissions

  • Remediation guidance with risk matrices and traceability

  • Gap analysis to strengthen ongoing cybersecurity practices

6. Retesting & Validation

Re-assessment after remediation to confirm vulnerabilities are fully addressed and compliance requirements are met.

Standards & Framework Alignment

Our VA/PT and security testing services adhere to internationally recognized standards:

Benefits of Working with Cyberintelsys

1. FDA Compliance Readiness

  • Well-structured cybersecurity evidence for FDA reviewers

  • Reduced risk of submission delays

2. Comprehensive Risk Mitigation

  • Early identification of high-risk vulnerabilities

  • Minimized financial, operational, and reputational risks

3. CREST-Certified Expertise

  • Testing conducted by certified ethical hackers

  • Globally recognized and repeatable assessment methodologies

4. Patient Safety & Trust

  • Enhanced protection of connected medical devices

  • Stronger confidence among healthcare providers and regulators

5. Continuous Security Improvement

  • Integration of findings into secure development lifecycle (SDLC)

  • Periodic testing to stay ahead of emerging threats

Medical Devices & Technologies Covered

Cyberintelsys supports VA/PT and security testing for:

  • Diagnostic devices (imaging, laboratory analyzers)

  • Therapeutic devices (infusion pumps, ventilators)

  • Patient monitoring and wearable devices

  • Medical software, SaMD, cloud platforms, and APIs

  • Embedded systems and IoMT devices

Why Choose Cyberintelsys in Canada?

  • CREST-accredited cybersecurity company trusted by regulators

  • Expertise across firmware, embedded systems, mobile, cloud, and IoMT devices

  • Regulatory knowledge spanning FDA 510(k), IEC 60601, IEC 81001-5-1, ISO, and NIST frameworks

  • Audit-ready documentation suitable for FDA submission

  • Canada-focused support and delivery model

Conclusion

For Canada-based medical device manufacturers, Medical Device Security Testing & VA/PT is essential to achieve FDA 510(k) cybersecurity compliance, protect patient safety, and reduce operational and regulatory risks.

Cyberintelsys provides CREST-accredited services that help manufacturers:

  • Identify and remediate cybersecurity vulnerabilities

  • Meet FDA 510(k) cybersecurity documentation expectations

  • Strengthen device security and patient trust

  • Ensure readiness for successful FDA submission

Partner with Cyberintelsys to secure your medical devices, demonstrate regulatory compliance, and gain confidence in the Canadian and international markets.

Reach out to our professionals

[email protected]