Premarket Medical Device Cybersecurity & TPLC Readiness

A HealthSec Alliance™ Case Study

Client: Global medical device manufacturer

Challenge

The client needed to unify its premarket cybersecurity and privacy frameworks across multiple product lines operating in regulated markets. Their quality management system (QMS) and design controls were mature but segmented between engineering, regulatory, and legal teams.

As new FDA and EU MDR expectations emerged covering cybersecurity documentation and patient data protection, the company faced mounting pressure to validate design, data protection, and lifecycle risk management practices. Privacy compliance under HIPAA, GDPR, and state-level laws also required harmonization with device design and verification processes.

Key objectives:

• Integrate cybersecurity and privacy into a single, audit-ready framework.

• Align lifecycle risk management with HIPAA, HITECH, and GDPR.

• Streamline premarket submissions for global regulators.

• Establish scalable processes for supplier and data-handling oversight.

Solution

The HealthSec Alliance™ designed and implemented a unified Premarket Cybersecurity and Data Privacy Program connecting engineering, quality, and security operations. The engagement leveraged the Trust Stack Framework to automate traceability, documentation, and compliance reporting across U.S., U.K., and EU markets.

Core Deliverables

• Privacy & Cyber Gap Assessment: Mapped controls against HIPAA, GDPR, and ISO/IEC 27001 to identify organizational gaps and supplier risks.

• Integrated Risk Management: Embedded ISO 14971 and AAMI TIR57 threat models within privacy and quality workflows.

• Secure Design Controls: Added privacy-by-design requirements to device software and validation plans.

• Policy & Training Framework: Established governance, awareness, and annual compliance training aligned with GDPR Articles 12–24.

• Regulatory Alignment: Produced audit-ready artifacts mapped to FDA 524B, IEC 62304, and MDR Annex I.

Results & Impact

• Unified Compliance: Combined cybersecurity and privacy oversight under one program covering HIPAA, GDPR, and medical device standards.

• Audit-Ready Documentation: Delivered complete evidence packages for FDA and EU MDR submissions.

• Operational Efficiency: Reduced redundant audits and review cycles by 35%.

• Lifecycle Assurance: Privacy, security, and risk management now validated throughout the total product lifecycle (TPLC).