MedTech Postmarket Cybersecurity and Risk Mitigation

A HealthSec Alliance™ Case Study

Client: Developer of adhesive-based medical identification and connected health technologies

Challenge

As the client expanded into connected health and identification systems, regulators and hospital partners required stronger postmarket cybersecurity, data integrity, and privacy oversight. Their existing risk processes focused on design-time controls but lacked structured postmarket threat analysis and documentation of vulnerability management.

Key challenges included:

• Inconsistent software and firmware inventories across manufacturing and service teams.

• Limited visibility into device vulnerability exposure and patch validation.

• Fragmented incident response and reporting documentation.

• Growing expectations for traceable, audit-ready cybersecurity evidence under FDA and EU MDR guidance.

Solution

The HealthSec Alliance™ designed a Postmarket Cybersecurity Risk Assessment Program that integrated privacy, safety, and security principles into the client’s existing quality management and engineering systems.

Core Deliverables

• Risk Identification & Threat Modeling: Defined critical assets, potential attack paths, and “what-if” scenarios tied to device use cases.

• Risk Evaluation & Documentation: Applied a standardized five-point risk matrix to rank, record, and track residual risk levels.

• SBOM and Vulnerability Mapping: Linked third-party components to known vulnerabilities and established version control across updates.

• Incident Traceability: Embedded cryptographically verifiable logs for each remediation and firmware release.

• Compliance Reporting: Delivered an audit-ready report mapped to FDA 524B, ISO 14971, and MDCG 2019-16 guidance.

Results & Impact

• Audit Readiness: Produced comprehensive, time-stamped documentation for Notified Body and FDA review.

• Operational Efficiency: Reduced duplicate assessments and reporting gaps by 40%.

• Continuous Vigilance: Enabled early detection of vulnerabilities and faster response coordination.

• Lifecycle Assurance: Integrated postmarket monitoring directly into the product risk management file.