IEC 81001-5-1

Medical Device Cybersecurity Consultancy

Cybersecurity Lifecycle Support for FDA and EU MDR Readiness

IEC 81001-5-1 based medical device cybersecurity consultancy is provided to support manufacturers preparing for FDA cybersecurity expectations, EU MDR cybersecurity requirements and international medical device security best practices.

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Cybersecurity Is Patient Safety

Modern medical devices are connected computers operating in clinical environments. Cybersecurity is directly linked to patient safety, clinical effectiveness, data integrity and regulatory compliance.

A secure medical device must be considered across three connected dimensions.

Patient

Protection of life, health and clinical decision-making.

Device

Protection of software, firmware, hardware interfaces and safety-critical functions.

Network

Protection of hospital connectivity, data transmission, cloud integration and remote access.

Why IEC 81001-5-1 Matters

IEC 81001-5-1 defines security-related activities in the health software product lifecycle and helps manufacturers build a structured cybersecurity framework across the entire product lifecycle.

FDA premarket
cybersecurity submission
preparation
EU MDR
cybersecurity
readiness
Secure development
lifecycle
implementation
Vulnerability management
and post-market
maintenance
Technical documentation
and regulatory
review

Relationship with Standards

IEC 81001-5-1 complements existing medical device software and risk management standards by adding cybersecurity lifecycle activities.

IEC 62304

Medical device software lifecycle processes.

ISO 14971

Medical device risk management.

FDA

FDA cybersecurity guidance.

EU MDR

EU MDR Annex I General Safety and Performance Requirements.

MDCG

MDCG guidance on medical device cybersecurity.

This combination helps manufacturers build an integrated framework covering software quality, safety risk management and cybersecurity risk management.

Support for FDA Cybersecurity Expectations

We help manufacturers prepare cybersecurity evidence aligned with FDA expectations throughout the product lifecycle.

  • Secure Product Development Framework review
  • Cybersecurity risk management planning
  • Threat modelling and security architecture review
  • SBOM preparation and component vulnerability review
  • Secure update and patch management planning
  • Vulnerability handling and disclosure process preparation
  • Cybersecurity testing evidence planning
  • Penetration testing and vulnerability assessment planning
  • Cybersecurity section support for FDA premarket submission
  • Post-market cybersecurity monitoring and maintenance planning
FDA cybersecurity support

Support for EU MDR Cybersecurity Readiness

We help manufacturers prepare cybersecurity-related technical documentation and process evidence for EU MDR compliance.

  • Mapping cybersecurity controls to MDR Annex I GSPRs
  • Alignment with MDCG cybersecurity guidance
  • Cybersecurity risk management integration with ISO 14971
  • Secure software lifecycle process review
  • Alignment with IEC 81001-5-1 health software lifecycle
  • Security requirement definition and traceability support
  • Vulnerability handling and security update planning
  • Post-market surveillance and cybersecurity monitoring support
  • Technical file cybersecurity evidence preparation
  • User security and clinical safety communication planning
EU MDR cybersecurity readiness

Our Consultancy Services

Cybersecurity Gap Assessment

Evaluate current processes and identify gaps against IEC 81001-5-1, FDA and EU MDR expectations.

Threat Modelling & Risk Management

Perform threat modelling and cybersecurity risk assessment aligned with ISO 14971.

Secure Development Lifecycle Review

Review and strengthen secure development practices across the software lifecycle.

Technical Documentation Support

Prepare cybersecurity sections of technical file or FDA submission documentation.

Vulnerability Management & Update Planning

Establish vulnerability handling, disclosure and secure update processes.

Testing & Verification Guidance

Plan cybersecurity testing, vulnerability assessment and penetration testing activities.

Products and Software We Support

Connected
Medical Devices
SaMD
Software in a
Medical Device
Health
Software
Mobile Medical
Applications
Cloud-connected
Medical Systems
Remote Monitoring
Devices
Wearable
Medical Devices

Typical Deliverables

  • IEC 81001-5-1 lifecycle gap assessment report
  • FDA cybersecurity readiness review
  • EU MDR cybersecurity readiness review
  • Threat model
  • Cybersecurity risk assessment support
  • Security requirement traceability matrix
  • SBOM preparation checklist
  • Software composition and component vulnerability review summary
  • Vulnerability handling process recommendation
  • Secure update and patch management recommendation
  • Cybersecurity testing strategy
  • Vulnerability scanning or penetration testing summary
  • FDA premarket cybersecurity evidence checklist
  • EU MDR technical documentation cybersecurity checklist
  • GSPR cybersecurity mapping support
  • Corrective action roadmap

Why Start Early?

Prepare Evidence Earlier

Build regulatory cybersecurity evidence before submission pressure appears.

Reduce Submission Delays

Avoid late-stage gaps caused by missing lifecycle cybersecurity documentation.

Align Safety and Security

Improve alignment between cybersecurity, safety and risk management activities.

Strengthen Post-market Readiness

Prepare vulnerability handling and monitoring processes across the product lifecycle.

Not Sure Where to Start？

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