MedTech software and engineering experience
Device-to-cloud engineering
V&V, quality and product security as part of the work
FHIR, HL7, DICOM and API integration
MedTech software and engineering experience
Device-to-cloud engineering
V&V, quality and product security as part of the work
FHIR, HL7, DICOM and API integration
Connectivity can make a device easier to monitor, service and update. It can also support new software features and give teams better visibility into how products are performing.
But every connection adds work across embedded software, cloud, cybersecurity, interoperability, validation and ongoing support. EZEN helps teams handle that work without separating each part into its own silo.
Sensors · hardware · firmware · embedded software
Device software, firmware, hardware-software integration, diagnostics
BLE · Wi-Fi · cellular · gateways · local processing
Connectivity architecture, protocol integration, edge logic, resilience
Device onboarding · APIs · services · telemetry · storage
Cloud architecture, device services, APIs, data ingestion
Analytics · anomaly detection · AI/ML where appropriate
Data engineering, operational analytics, model integration and monitoring
Patient apps · clinician portals · service dashboards
Web/mobile engineering, UX and workflow integration
EHR/EMR · hospital systems · FHIR · HL7 · DICOM
Interoperability, integration, data mapping and API enablement
Cybersecurity · quality · V&V · privacy · traceability
Security-by-design, risk controls, verification and lifecycle evidence
We support the device side of connected products, including embedded software, firmware, sensors and communication interfaces.
Embedded software · firmware · interface integration · diagnostics
We build the path between the device and the cloud, including onboarding, telemetry, APIs and device services.
Cloud architecture · APIs · telemetry pipelines · device services
We connect device data with healthcare and enterprise systems using the standards and APIs that fit the product environment.
FHIR · HL7 · DICOM · REST APIs · interface mapping
We build patient, clinician, caregiver and service applications that make connected-device data useful in day-to-day workflows.
Mobile/web apps · portals · dashboards · workflow integration
We address security across the device, communications, cloud, applications and post-market lifecycle.
Threat modeling · secure design · SBOM support · vulnerability remediation
We help teams use device data for dashboards, operational insight, anomaly detection and AI or ML use cases where they make sense.
Data pipelines · dashboards · anomaly detection · AI/ML integration
We test the connected system across device, interface, cloud, application and security layers, with traceability back to requirements.
Integration testing · regression automation · performance/reliability · traceability
We help extend the life of established products through software updates, platform modernization and ongoing lifecycle engineering.
Legacy assessment · modernization roadmap · remote support · lifecycle engineering
Remote patient monitoring
Connected diagnostics
Connected drug delivery
Connected surgical & procedural systems
Home healthcare
Fleet & remote service
Connected imaging
For connected medical devices, cybersecurity, quality and V&V cannot be added at the end. They need to be considered in requirements, architecture, interfaces, software changes, testing and post-market support from the start.
Security lifecycle
Identify → Design → Build → Verify → Release → Monitor → Respond
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Security focus
Threat modeling · secure architecture · identity/authentication · encryption · secure APIs · SBOM support · vulnerability management · secure updates · post-market support
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Regulatory / quality context
Depending on the device and target market, relevant requirements may include FDA medical-device expectations, FDA QMSR, ISO 13485, ISO 14971, IEC 62304, IEC 62366-1, IEC 81001-5-1 and IEC 60601.
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Disclaimer
The standards and regulatory requirements that apply depend on the device, intended use, architecture and target market. EZEN supports engineering and evidence preparation; final regulatory decisions remain with the legal manufacturer and relevant authorities.
Many installed products were designed before cloud connectivity and current cybersecurity expectations became common. When the architecture allows it, EZEN can help modernize the software and connectivity around an existing device without forcing a full redesign.
Gateway architectures · API enablement · software/platform modernization · secure update approaches · device management · remote diagnostics · cloud migration · regression automation
A modular device-to-cloud architecture can make software features easier to add, update and maintain.
Discovery, feasibility and product roadmap
System and software architecture
Technology and platform selection
Interface, data-flow and release planning
Telemetry can give engineering and service teams better visibility into devices in the field.
Embedded applications, firmware and device-control software
Drivers, middleware, sensors and instrument integration
Hardware-software integration, diagnostics and logging
Performance, reliability and update mechanisms
Security is addressed across the device, software, connectivity and cloud throughout the product lifecycle.
Clinical workflow and user research
Touchscreen, workstation and device-panel interfaces
Data, image, alarm and status visualization
Usability risk-control implementation and GUI verification
Standards-based integration can reduce unnecessary custom interfaces where the environment supports it.
Discovery, feasibility and product roadmap
System and software architecture
Technology and platform selection
Interface, data-flow and release planning
Integrated V&V and traceability make it easier to connect what was built with the evidence needed for release and review.
Embedded applications, firmware and device-control software
Drivers, middleware, sensors and instrument integration
Hardware-software integration, diagnostics and logging
Performance, reliability and update mechanisms
Share the device, its stage of development and the target submission date. An EZEN specialist will respond with an initial view of readiness and recommended next steps.