Cybersecurity for Healthcare & Medical Device Manufacturers

1. Threat Model

Comprehensive threat analysis aligned with PASTA methodology and FDA expectations

2. Cybersecurity Risk Assessment

Risk evaluation considering safety and security impacts

3. Security Architecture Views

Documentation of security controls and design decisions

4. SBOM

Complete software bill of materials meeting FDA format requirements

5. Vulnerability Analysis

Assessment of known vulnerabilities in device components

6. Unresolved Anomaly Documentation

Tracking of security issues and compensating controls

7. Security Testing Documentation

Evidence of security testing activities and results

8. Cybersecurity Management Plan

Postmarket vulnerability monitoring and response procedures

9. Customer Security Documentation

User guidance for secure deployment and operation

10. Labeling Content

Cybersecurity information for device labeling

11. Regulatory Correspondence

Responses to FDA cybersecurity questions

12. Lifecycle Support Plan

End-of-life and end-of-support planning

Our PASTA methodology is uniquely suited to medical device security because it:

• Starts with business and clinical context – Understanding how the device is used in care delivery
• Considers patient safety threats – Not just confidentiality, but risks to patient health and life
• Models realistic attack scenarios – Based on actual threat intelligence, not theoretical risks
• Produces FDA-aligned documentation – Outputs that satisfy regulatory expectations
• Prioritizes by impact – Helping product teams focus on risks that matter most

Sample PASTA Outputs for Medical Devices

Design Phase Security

• Security requirements definition early in development
• Threat modeling integrated into design reviews
• Architecture guidance for secure-by-design approaches
• Component selection security considerations

Development Phase Security

• Secure coding practices and training
• SAST/DAST integration into development workflows
• Dependency management and SBOM generation
• Code review support for security-critical components

Verification & Validation

• Penetration testing of device software and firmware
• Fuzz testing for protocol and interface robustness
• Hardware security assessment where applicable
• Integration testing for connected device ecosystems

Premarket Submission Support

• Cybersecurity documentation preparation
• FDA Q-Sub meeting support for cybersecurity questions
• Reviewer question response assistance
• 510(k), De Novo, and PMA cybersecurity sections

Postmarket Security

• Vulnerability monitoring program development
• Coordinated disclosure process design
• Patch management strategy
• Customer communication procedures
• End-of-life planning

Diagnostic & Imaging Equipment

• CT, MRI, X-ray, ultrasound systems
• Laboratory analyzers and diagnostics
• Point-of-care testing devices
• Digital pathology systems

Therapeutic Devices

• Infusion pumps and medication delivery
• Surgical robotics and navigation
• Radiation therapy systems
• Dialysis equipment

Patient Monitoring

• Vital signs monitors
• Telemetry systems
• Remote patient monitoring platforms
• Alarm management systems

Implantable Devices

• Cardiac rhythm management (pacemakers, ICDs)
• Neurostimulation devices
• Drug delivery implants
• Cochlear implants

Wearables & Consumer Health Devices

• Continuous glucose monitors
• Wearable ECG monitors
• Connected fitness devices
• Digital therapeutics

Software as a Medical Device (SaMD)

• Clinical decision support
• Diagnostic algorithms
• AI/ML-enabled diagnostics
• Companion applications

Healthcare Equipment & Apparel

• Hospital beds and furniture
• Surgical instruments
• Protective equipment
• Healthcare facility systems

20+ Years of Healthcare Experience

We’ve been working with healthcare organizations and manufacturers since before the first FDA cybersecurity guidance existed. We’ve watched the regulatory landscape evolve and helped clients adapt at every stage.

Deep Product Security Expertise

Our team includes professionals with extensive experience in medical device development, embedded systems security, and FDA regulatory processes. We speak both security and regulatory fluently.

Risk-Centric Methodology

PASTA was designed to align security with business objectives-making it ideal for medical device environments where regulatory compliance, patient safety, and time-to-market must all be balanced.

Practical, Actionable Guidance

We understand that you can’t redesign your device to address every theoretical risk. We help you prioritize, develop compensating controls, and build documentation that supports defensible risk acceptance decisions.

Manufacturer-Trusted Partner

We’ve worked with some of the world’s largest healthcare manufacturers on their most critical products. We understand the pressure you’re under and the stakes involved.