Medical Device Cybersecurity & Compliance Consulting
Build security into connected medical devices, SaMD, and health software from early design through regulatory submission and post-market operation.
Security Built Into
the Device Lifecycle
Pure Global brings regulatory, quality, software, and cybersecurity work into one coordinated program. We help teams identify gaps early, produce traceable evidence, and maintain security as products and threats evolve.
Integrated Regulatory
and Cybersecurity Support
Connected technologies, SaMD, wireless communications, and cloud-enabled systems have made cybersecurity a core part of medical device safety, quality, and performance. We align regulatory strategy, technical documentation, risk controls, and validation across the full product lifecycle.
Regulatory strategy
Device classification, pathway selection, FDA predicate assessment, EU MDR classification, and conformity assessment planning.
Design controls and documentation
Traceable design, quality, software, and technical documentation aligned with FDA QMSR, ISO 13485, IEC 62304, and EU MDR Annexes II and III.
Risk, safety, and performance
Risk management, usability, clinical evaluation, electrical safety, essential performance, and EMC planning using applicable standards.
Testing and lifecycle support
Verification, validation, submission support, vulnerability management, software maintenance, and post-market compliance activities.
FDA Medical Device
Cybersecurity
FDA premarket review now treats cybersecurity and software assurance as essential parts of device safety and effectiveness. We help teams prepare the design evidence, risk documentation, and lifecycle plans expected for devices with cybersecurity risk.
Classification and predicate strategy
Define the regulatory pathway, identify suitable predicates, and build a defensible substantial-equivalence rationale.
Premarket cybersecurity evidence
Prepare threat models, cybersecurity risk assessments, architecture views, testing evidence, labeling, and vulnerability-management plans.
QMSR and software alignment
Connect FDA QMSR, ISO 13485, IEC 62304, ISO 14971, and IEC 81001-5-1 activities with clear design and risk traceability.
Submission and review support
Assemble submission-ready cybersecurity content and support responses to FDA requests for additional information.
EU MDR Cybersecurity
and Compliance
EU MDR places software, information security, risk control, and post-market obligations within the device's safety and performance framework. We help manufacturers connect those requirements to technical documentation and an audit-ready quality system.
Gap assessment and pathway
Review existing documentation and cybersecurity maturity, confirm device classification, and define the conformity assessment route.
Technical and clinical evidence
Build Annex II and III documentation covering design, performance, clinical evaluation, risk, and software lifecycle evidence.
Security and quality integration
Align ISO 14971, IEC 62304, IEC 81001-5-1, and ISO 13485 processes for secure development and defensible traceability.
Post-market and audit readiness
Establish surveillance, vigilance, incident handling, vulnerability remediation, PSUR support, and notified body preparation.
Medical Device
Security Assessment
We evaluate the device and its surrounding ecosystem to identify exploitable weaknesses, test existing controls, and prioritize remediation by technical severity, patient safety impact, and regulatory relevance.
Attack surface mapping
Review device architecture, firmware, embedded systems, wireless interfaces, mobile apps, APIs, cloud services, and hospital integrations.
Controlled penetration testing
Apply black-box, white-box, or gray-box methods within agreed safety boundaries to validate real-world exploitability.
Clinical impact prioritization
Evaluate findings against device integrity, therapy continuity, sensitive data, operational reliability, and patient safety.
Remediation and verification
Deliver actionable findings mapped to relevant frameworks, then retest fixes and support ongoing vulnerability management.
IEC 81001-5-1
Compliance Services
IEC 81001-5-1 provides a lifecycle framework for improving the security of health software. We help product and quality teams translate its processes, activities, and tasks into practical governance, development, verification, and maintenance controls.
Gap assessment and governance
Evaluate current practices, clarify roles and policies, and establish a risk-based implementation roadmap.
Secure lifecycle integration
Embed threat modeling, secure design and coding, verification, supplier oversight, and change control into the software lifecycle.
Verification and evidence
Plan security testing and maintain traceable records that support internal audits, regulatory submissions, and external assessments.
Operations and maintenance
Support monitoring, patching, incident response, vulnerability remediation, documentation updates, and continuous improvement.
One Program from Design to Post-Market
Choose focused support for a specific gap or combine services into a coordinated cybersecurity and compliance workstream.
Regulatory Strategy
Map cybersecurity obligations to device classification, target markets, submission pathways, and evidence plans.
Secure Development
Integrate security activities into product, software, quality, and supplier processes from the start.
Risk & Threat Modeling
Connect cybersecurity hazards, threat scenarios, control decisions, and patient safety impact.
Testing & Validation
Coordinate architecture reviews, vulnerability assessment, penetration testing, and remediation verification.
Submission Evidence
Build clear, traceable cybersecurity documentation for FDA, EU MDR, and other regulatory reviews.
Post-Market Support
Maintain vulnerability monitoring, incident readiness, change records, and regulatory compliance after launch.
One Security Program,
Multiple Markets
Coordinate a consistent cybersecurity foundation while adapting evidence, submissions, and post-market activities to each target market.
Let's Talk,
Anywhere You Are.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
Contact us