Aligning with Health Canada’s MDR, ISO & IEC Expectations

Health Canada Penetration Testing Services

This plan provides a clear path to compliance, safety, and market readiness, ensuring your devices are secure from design to deployment.

Discovery Session

Our Services

Health Canada Penetration Testing Services

We provide end-to-end penetration testing for medical devices, aligned with Health Canada’s Medical Device Regulations (MDR) and global cybersecurity standards (ISO 14971, IEC 62304, IEC 81001-5-1). Our structured 3-phase approach ensures medical devices are secure, compliant, and resilient throughout their lifecycle — from design to postmarket monitoring.

Our Phases

Our Health Canada Penetration Testing Services Process

We establish a regulatory-compliant testing foundation by reviewing Health Canada requirements, SBOMs, and risk files.

Activities

Review Health Canada’s cybersecurity requirements under the Medical Device Regulations (MDR) and related standards (ISO 14971, IEC 62304, IEC 81001-5-1).
Define scope and identify target systems (devices, firmware, software, connected ecosystems).
Conduct documentation review of SBOMs, risk management files, vulnerability disclosure policies, and cybersecurity management plans.
Build threat models tailored to medical device risks: unauthorized access, PHI disclosure, device malfunction, and safety hazards
Define security controls: encryption, authentication, access control, secure boot.

Deliverables

Regulatory-aligned test plan (Health Canada MDR + ISO/IEC references)
Threat model & risk prioritization matrix
Gap analysis report of existing documentation and controls

Activities

Perform hardware & firmware security testing: access controls, secure boot, encryption, tamper resistance.
Conduct software & connectivity testing: APIs, wireless protocols (Bluetooth, Wi-Fi, cellular, proprietary), interoperability with healthcare IT.
Validate lifecycle security: patch/update processes, secure deployment, end-of-life handling.
Assess data privacy & PHI protection in transmission and storage per Health Canada privacy expectations.

Deliverables

Penetration test report with vulnerabilities & exploitation findings
Risk register with CVSS scoring + impact on patient safety & PHI
Remediation roadmap for premarket and quality system integration

Activities

Test incident response readiness: simulated attacks, detection, containment, recovery.
Evaluate postmarket monitoring systems for vulnerability scanning, SBOM updates, and continuous threat intelligence integration.
SPerform supply chain security review: third-party components, libraries, wireless modules, compliance with MDR expectations.
Validate patch/update verification: ensuring security fixes do not introduce new vulnerabilities or disrupt device safety/functionality.
Prepare regulatory-compliant documentation for Health Canada submissions and internal QA.

Deliverables

Postmarket penetration test report
Incident response readiness report
Supply chain assessment (third-party risk + compliance verification)
Final compliance package (submission-ready reports, mitigation evidence, ongoing monitoring recommendations)

Our Process

Cybersecurity Evaluation Process

Securing the Future of Connected Health

A proactive, data-driven approach to Medical Device Cybersecurity that ensures safety, compliance, and patient trust from concept to market.

CyberSecurity Data Driven Insights for C-Suite Executives

Benefits

Health Canada Penetration Testing Services- Key Benefits

Provides end-to-end security validation across device design, premarket, and postmarket stages, reducing vulnerabilities and enhancing regulator confidence.

Key Benefits

End-to-End Security: Covers device design, deployment, and postmarket operations.
Regulatory Confidence: Evidence aligned with Health Canada MDR and ISO/IEC standards.
Patient Safety & Trust: Ensures PHI protection and reduces risk of device malfunction.
Market Access Readiness: Documentation prepared for regulatory submissions.

Why Our Structured Approach Matters

This tailored approach directly supports our core differentiator - the integrated, end-to-end solution by focusing on All-in-One AI/ML and Cybersecurity Solution, from Report to Roadmap and continuous partnership Premarket to Post-Market.

Our Methodology

Looking for Something Else ?

Rigorous testing to ensure the device is ready for regulatory approval and market release.

SBOM & Vulnerability Assessments

Regulatory-focused 3-phase structured service plan to market SBOM (Software Bill of Materials) and vulnerability management services to medical device manufacturers and SaMD startups. This plan emphasizes pre-market and post-market compliance under FDA, EU MDR, and other global regulations. The objective of this service offering is to meet and exceed current and future regulatory requirements while reducing cyber risk, streamlining submissions, and building customer trust in the security and transparency of their devices.

Threat Modeling and Vulnerability Assessments

Our Threat Modeling and Vulnerability Assessment service provides a structured approach to identifying and mitigating cybersecurity risks in connected medical devices and SaMD solutions. By aligning with global regulatory frameworks such as FDA Premarket Guidance, EU MDR, IEC 62443, and ISO 14971, we help manufacturers proactively secure their devices, reduce risk, and streamline premarket and postmarket compliance.

Medical Device CyberSecurity Assessment

The Medical Device Cybersecurity Assessment provides a comprehensive, lifecycle-focused framework to secure connected devices against evolving threats. Our approach integrates regulatory guidance from FDA, EU MDR, and Health Canada with rigorous design reviews, penetration testing, and postmarket monitoring. By embedding security from the earliest stages through ongoing surveillance, manufacturers can reduce cyber risk, accelerate approvals, and maintain long-term patient trust and regulatory compliance.

Medical Device Penetration Testing

Our Penetration Testing Services provide medical device manufacturers with rigorous, regulator-aligned assessments to validate cybersecurity resilience before and after market release. By integrating FDA premarket/postmarket guidance, EU MDR, and IEC standards, we help organizations reduce vulnerabilities, accelerate compliance, and safeguard patient safety across the full device lifecycle.

Medical Device Cybersecurity Validation & Testing

Our Cybersecurity Validation Testing methodology integrates global regulatory standards (FDA, EU MDR, IEC 62304/62443) with proven security best practices. We help manufacturers strengthen device resilience, achieve faster regulatory approval, and build long-term trust with patients and healthcare providers.

Recommendations

Key Recommendation for
Manufacturers

Incorporate threat modeling early in design, continuously monitor vulnerabilities, and implement security controls with traceable documentation to maintain compliance and protect patient safety throughout the device lifecycle.