Healthcare & MedTech

ISS secures connected medical devices, digital health platforms, and healthcare systems across their full operational lifecycle. From device design and manufacturing to clinical deployment and patient care, ISS delivers embedded cryptographic trust, lifecycle governance, and regulatory-aligned assurance to ensure implants, diagnostics, connected equipment, and AI-driven systems remain safe, traceable, and compliant in highly regulated environments.
Healthcare & MedTech

About Healthcare & MedTech

Healthcare and medical technology depend on complex, connected systems that span devices, software, cloud platforms, supply chains, and clinical operations. From life-saving implants and diagnostic equipment to hospital networks, remote monitoring, and AI-assisted care, patient safety and regulatory compliance require trust that extends far beyond the device itself.

ISS delivers this trust by embedding security at the silicon and system level, governing identities, credentials, and software integrity across the lifecycle, and providing expert services aligned to healthcare regulations and safety standards. ISS secures device identities, firmware and software updates, cryptographic keys, certificates, and secrets while ensuring traceability, auditability, and compliance from development through deployment and post-market surveillance.

Related Solutions

Post-Quantum & Crypto Agility Readiness

Modernize cryptography for the post-quantum era — with full discovery, assessment, and migration readiness.
Prepare for future cryptographic standards with managed certificate and key transitions. Enable secure hybrid algorithms without disrupting core business operations.

Secure Software & Firmware Signing

Centralized, policy-controlled code signing and update validation from development to deployment.

AI & Agent Identity Assurance

AI agents are autonomous software entities that act, decide, and operate without human intervention. Like devices, services, and users, they require strong identity, cryptographic control, and enforceable policy to be trusted in production environments. ISS extends Trust Lifecycle Management (TLM) to AI agents – treating them as first-class machine identities governed through the same platform that secures devices, enterprise systems, and cloud workloads.

Trust Intelligence & Analytics

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Continuous visibility into cryptographic trust posture across devices, workloads, and identities.

Secure Supply Chain & Manufacturing Trust

Secure supply chain and manufacturing trust requires continuous verification across devices, software, and partners. This solution establishes cryptographic trust from production to deployment, providing centralized visibility and control over assets, updates, and identities – across your organization and extended supply chain.

Worldwide Trusted By

  • Medical Device Makers
  • Hospitals
  • Digital Health Innovators

What We Offer?

  • Secure ID and access control for connected medical devices.
  • Deliver SBOM/CBOM for compliance, monitoring, and recall readiness.
  • Support continuous compliance across FDA, HIPAA, and EU MDR frameworks.
  • Protect secrets and keys inside devices with automated rotation.
  • Enable secure OTA updates to medical devices and hospital infrastructure.

Key Regulatory Drivers

  • FDA 21 CFR Part 11, Part 820
  • FDA 524B (cybersecurity for medical devices)
  • HIPAA security requirements
  • IEC 62304 (software lifecycle for medical devices)
  • ISO 13485 (QMS for medical devices)

Related Case Studies

Aerospace & Defense Industry

A leading supplier of mission-critical engine control units (ECUs) for U.S. military applications needed a way to securely transport firmware and key material to deployed systems - without relying on external connections, internet access, or physical vendor presence. The solution needed to meet government STIG standards, protect against tampering, and ensure end-to-end integrity from factory to edge-deployed systems.

Aerospace & Defense Industry

A leading A&D prime contractor supporting the U.S. Missile Defense Agency (MDA) was developing next-generation defense capabilities. The customer faced the critical challenge of securely delivering cryptographic key material and mission-critical firmware directly to deployed devices - while eliminating human touchpoints, reducing risk of compromise, and aligning with STIG compliance mandates. Traditional models depended on manual processes, air gaps, and on-prem security protocols that could no longer scale to the desired automation, assurance, and operational tempo.

Automotive & Connected Vehicles Industry

A global Tier-1 automotive supplier needed to protect the provisioning and management of sensitive credentials and firmware used in embedded Electronic Control Units (ECUs) across their supply chain. With increasing risks from unauthorized access, rogue diagnostics, and counterfeit components, the customer turned to ISS to automate and secure the lifecycle of ECU authentication—from initial password generation to in-field service validation.

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Get Started with Healthcare & MedTech

    Resource Library

    Post-Quantum Cryptography Implementation Guide

    Deep dive into post-quantum crypto deployment strategies for embedded systems

    Post-Quantum Cryptography Implementation Guide

    Deep dive into post-quantum crypto deployment strategies for embedded systems
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