Embedded solutions and SaMD built for compliance. Relevant’s senior teams deliver custom software for medical devices engineered to IEC 62304, FDA, and CE standards.
Medical devices have unique functional requirements, regulatory constraints, and integration dependencies. We build custom software for medical devices from the ground up. It’s designed for your hardware environment, clinical use case, and certification the product requires.
Software as a Medical Device is subject to strict regulatory scrutiny. Our end-to-end SaMD development services cover product definition, risk classification, architecture, development, and validation. All are aligned with the FDA, MDR, and IMDRF frameworks.
Real-time performance, hardware reliability, and safety-critical logic require a different engineering discipline than standard software. Our engineers build firmware and low-level software for medical devices where failure is not an option.
Thorough V&V documentation is what gets medical device software past regulators. Our team covers functional testing, risk-based test planning, IEC 62304-compliant documentation, and independent verification for new and legacy systems.
Architecture decisions made early determine if your product scales, certifies, and updates cleanly. We deliver software design for medical devices with an IEC 62304 lifecycle structure, a modular architecture, and built-in regulatory traceability.
Outdated architectures create certification gaps that slow product development. Our team modernizes legacy medical device software without interrupting device functionality. This implies upgrading architecture, documentation, and compliance posture in parallel.
Connected medical devices introduce security, interoperability, and data-integrity requirements that standard embedded development doesn’t address. Our software engineering services handle connectivity protocols, cybersecurity controls, and cloud integration alongside device-side firmware.
Good code doesn’t pass regulators without the right documentation. We produce and maintain Software Requirements Specification, Software Design Specification, risk management files, and traceability matrices for FDA 510(k), CE marking, and ISO 13485 submissions.
Regulatory frameworks for medical device software are detailed, non-negotiable, and change with product classification. Our software design for medical devices integrates IEC 62304 lifecycle structure, risk management per ISO 14971, and FDA 21 CFR Part 11 requirements from architecture through validation.
Delays in medical device software certification stem from incomplete documentation, poor traceability, or V&V gaps discovered late. We structure development so that regulatory artifacts, such as SRS, SDS, risk files, and traceability matrices, are built alongside the code.
In medical device software, a bug is a patient-safety issue. Our engineers apply rigorous hazard analysis, failure mode assessment, and safety architecture design to ensure the system behaves correctly under all operating conditions.
Older medical device software often lacks the architecture documentation and compliance traceability required for modern regulatory submissions. Modernizing these systems without disrupting device operation demands a structured approach.
Medical devices operating in clinical environments can’t tolerate latency, memory overflows, or timing failures. Our embedded software engineers build firmware with deterministic behavior, hardware abstraction layers, and real-time OS integration suited to the device’s clinical use case.
Connected medical devices are high-value targets for cyberattacks. FDA premarket cybersecurity guidance and MDR requirements demand threat modeling, secure boot, encrypted communication, and post-market vulnerability monitoring built into the software engineering process.
Medical device software doesn’t operate in isolation. Connecting devices to EHR platforms, hospital networks, and clinical data systems requires HL7 FHIR expertise, interoperability architecture, and security controls that match the clinical environment’s compliance posture.
Updating medical device software post-certification triggers re-validation requirements that teams underestimate. We build change management processes and modular architectures that make post-market updates traceable, testable, and compliant with ongoing regulatory obligations.
Machine learning models trained on imaging, sensor, and clinical data help medical devices detect conditions earlier and more accurately. Alongside this, it reduces diagnostic error and supports clinicians with evidence-based recommendations at the point of care.
AI models analyze operational data from medical devices in real time, identifying anomalies and predicting failures before they affect clinical use. Maintenance becomes proactive, and device uptime improves measurably.
Deep learning pipelines process X-ray, MRI, CT, and pathology imaging data to identify patterns that are not readily visible in clinical practice. We build and validate computer vision models that meet the accuracy and safety thresholds required for SaMD classification.
Unstructured clinical notes, device logs, and patient records contain information that databases miss. NLP models extract, classify, and route that data, which allows you to turn noise into signals that care teams and device manufacturers can act on.
Connected devices generating continuous physiological data need intelligent filtering to separate meaningful alerts from noise. AI models trained on patient-specific baselines detect deterioration patterns early and trigger clinically relevant alerts without overwhelming care teams.
Medical devices serving diverse patient populations benefit from software that adjusts to individual physiology, usage patterns, and clinical context. We develop adaptive AI algorithms that optimize device behavior per patient. Our team makes this within the validated operating envelope required for regulatory approval.
Training AI models on sensitive medical device data without centralizing patient records is a regulatory and ethical requirement. Federated learning architectures let models improve across distributed data sources while keeping PHI on-device and HIPAA-compliant.
IEC 62304, FDA 21 CFR Part 11, ISO 14971, CE marking: our team understands the standards medical device software must meet and structures development around them. Compliance documentation is produced alongside the code.
Medical device software requires engineers who understand safety-critical architecture, embedded constraints, and regulatory traceability. Every team we field is senior-heavy, with deep experience in regulated healthcare environments.
With 96% employee retention, the engineers who start your medical device software project are still there when you reach certification. No mid-project replacements, knowledge restarts, or gaps in regulatory documentation continuity.
From embedded firmware to SaMD and cloud-connected device platforms, our track record spans the full range of medical device software complexity. 246 projects delivered and 98% client satisfaction are documented outcomes.
Every engineer, QA specialist, and technical architect working on your project is employed directly by Relevant. You don’t worry about third-party vendors, offshore handoffs, and accountability gaps between teams.
As this is a regulated discipline, our process is built to deliver compliant, safety-critical software on time. It also includes documentation, traceability, and clinical alignment at every stage.
We define regulatory pathway, software classification under IEC 62304, and risk levels before architecture work begins. These decisions shape the depth of documentation, testing requirements, and the validation scope for everything that follows.
Architecture, system requirements, and IEC 62304-compliant lifecycle structure are locked in before development starts. Our team covers safety constraints, hardware integration, real-time requirements, and the traceability that regulators will audit.
Senior engineers build in iterations with regulatory artifacts, where risk management files, traceability matrices, and verification records are updated continuously. This way, your documentation stays up to date with the codebase.
Functional testing, risk-based test planning, and independent V&V run against the Software Requirements Specification. For SaMD, clinical validation is documented to meet FDA and MDR standards. No submission moves forward without an auditable test record.
We support submissions for FDA 510(k), CE marking, and ISO 13485. Technical documentation, regulatory queries, and post-approval change control included. As your device evolves, we ensure every update remains traceable, validated, and compliant.
Our medical devices software development process is built around IEC 62304 for lifecycle, ISO 14971 for risk management, FDA 21 CFR Part 11 for electronic records, and MDR/IVDR for CE marking. ISO 13485 quality management requirements are applied across documentation and development practices. Standards are selected based on your device’s regulatory pathway and software safety classification.
Cybersecurity is addressed at the architecture level. Our software engineering for medical devices covers threat modeling, secure boot, encrypted communication, role-based access controls, and post-market vulnerability monitoring. It’s aligned with FDA premarket cybersecurity guidance and MDR requirements for connected and IoMT devices.
Yes. EHR and EMR integration is a standard part of our software services for medical devices. We use HL7 FHIR and custom API development to connect device software with Epic, Cerner, Athenahealth, and other major platforms. Our team also ensures that data integrity and compliance controls align with the clinical environment’s security posture.
We produce and maintain the full regulatory documentation package, including the Software Requirements Specification, Software Design Specification, risk management files, traceability matrices, V&V test records, and cybersecurity documentation. All artifacts are structured to support FDA 510(k), De Novo, or PMA submissions, depending on device classification.
Yes. Our software developers for medical devices cover the full connected stack, including device-side firmware, a cloud backend, and companion mobile applications. Security, interoperability, and regulatory compliance are built into every layer, including data transmission protocols and cloud infrastructure architecture.
Our team develops and validates AI and ML models for medical device applications, e.g., diagnostic support, predictive monitoring, computer vision, and adaptive device behavior. For SaMD, AI model development follows the FDA’s Total Product Lifecycle framework and predetermined change control plan requirements.
Medical devices’ embedded software testing is planned from the start based on IEC 62304 safety classification and ISO 14971 risk assessment. It covers functional verification, integration testing, system validation, and, for SaMD, clinical performance validation. All activities are documented in auditable records aligned with the target regulatory pathway.
SaMD is software that performs a medical function independently of hardware. These can be diagnostic apps, clinical decision support tools, AI-powered monitoring platforms, etc. Development for SaMD follows a stricter regulatory path than embedded device software: risk classification under IMDRF and IEC 62304, clinical validation requirements, and FDA or MDR pre-market review, depending on the intended use and risk level. Our team handles the full SaMD development lifecycle, from product definition and risk classification through architecture, development, V&V, and regulatory submission.
Medical device software development doesn’t end at launch. We support post-market change management, software updates, revalidation, and ongoing regulatory compliance. Your device stays certifiable as it evolves.
If regulatory gaps are slowing your device to market, we’re here to help.
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