Medical Device Software Development Services
Medical device software development services cover the design, engineering, verification, and regulatory documentation of software inside a device or acting as a medical device on its own. Ailoitte builds these to IEC 62304 and ISO 14971, so healthcare and MedTech teams ship safe, submission-ready products faster.
Medical device software isn't an app with extra paperwork. It's a safety discipline.
A consumer app can ship, break, and be patched next sprint. A regulated device cannot. Every requirement has to trace to a test, every risk to a control, and every release to an auditable record before it reaches a patient. That is why our medical device software development services put the IEC 62304 lifecycle and ISO 14971 risk management at the center of engineering, not bolted on at the end for a submission scramble.
What Are Medical Device Software Development Services?
Medical device software development is the engineering of software that either runs inside a medical device (SiMD) or functions as a medical device on its own (SaMD), built to regulatory standards, chiefly IEC 62304 for the software lifecycle and ISO 14971 for risk management, so it can be safely cleared and marketed. Our medical device software development services span three recognized software categories.
SaMD — Software as a Medical Device
Standalone software with a medical purpose that runs on a general-purpose platform such as a phone, tablet, or PC. Examples: DICOM image viewers, clinical decision support, and diagnostic apps.
SiMD — Software in a Medical Device
Software or firmware embedded in a physical device and required for it to function, such as the control software inside an infusion pump, glucose monitor, or ECG sensor.
Software accessories
Companion apps, device-management dashboards, cloud platforms for connected fleets, and calibration tools that drive, configure, or extend a medical device.
Diagnostic software, built for clarity and clearance
We build Software as a Medical Device that clinicians can trust, from DICOM image viewers to AI-assisted detection, with every finding traceable back to a verified requirement and test.
- DICOM viewing with pan, zoom, window, and measure controls
- AI-assisted findings surfaced for clinician review, never in place of it
- Verification and validation evidence prepared for FDA and MDR submission
Medical Device Software Built for Regulated Teams
We deliver medical device software development services across the full product lifecycle, as part of Ailoitte's wider healthcare software development work, for organizations that carry real regulatory weight.
Medical device & MedTech manufacturers
Adding software, connectivity, or a companion app to existing or new hardware.
SaMD & digital health startups
Launching a first regulated product and needing a clearance-ready lifecycle from day one.
In vitro diagnostics (IVD) companies
Building analysis, reporting, and lab-connectivity software under IVDR.
Hospitals & health systems
Integrating devices with EHR and EMR and embedding them in clinical workflows.
Pharma, CROs & research
Connected-device data capture and analytics for trials and studies.
Class II and Class III programs
Across IEC 62304 software safety classes A, B, and C, including high-risk implantables.
Our Medical Device Software Development Services
End-to-end medical device software development services across the full lifecycle. Each capability can run on its own or as part of a combined, outcome-based engagement.
Consulting & regulatory strategy
We assess your device, intended use, and target markets, then define software classification, applicable standards, and a lifecycle plan that keeps engineering and regulatory work aligned from the start.
SaMD & embedded engineering
Our medical device software development services build SaMD, embedded software and firmware, and software accessories, with architecture designed for configurability, traceability, and adding new device types with minimal rework.
Verification & validation
Multi-level QA aligned to IEC 62304 and your risk file, covering unit, integration, system, and validation testing, with full traceability from requirement to test case for your Design History File.
Regulatory documentation & submission support
We produce the technical documentation regulators require, including the software development plan, design specs, ISO 14971 risk file, verification records, and the Design History File, to support FDA 510(k), De Novo, PMA, EU MDR, and IVDR.
Integration & connectivity
We connect medical device software and SaMD to EMR and EHR systems via FHIR R4 and HL7, to imaging via DICOM, and to the wider IoMT across Bluetooth and BLE, NFC, Wi-Fi, 5G, and cellular IoT.
Maintenance & post-market evolution
Our medical device software development services include post-market support, security patching, performance monitoring, and change management that preserve your compliance posture as the product evolves.
Every device connection, secured end to end
Our medical device software connects wearables, sensors, and bedside equipment to the cloud over Bluetooth LE and cellular IoT, streaming live signals with encryption and integrity checks at every hop.
- Bluetooth LE and IoMT pairing with clear connection status
- Encrypted, real-time telemetry from device to cloud
- Firmware and configuration management for connected fleets
Medical Device Software Use Cases We Build
Where our medical device software development services are most often applied across connected care, diagnostics, and therapy.
Remote patient monitoring
Continuous capture of vitals from connected devices, with clinician alerting on critical changes.
Wearable & implanted device software
On-body sensors and smart therapeutic devices such as insulin pens and smart inhalers.
Diagnostic & imaging software
Image analysis, DICOM viewers, and AI-assisted detection and triage.
Chronic disease management
Diabetes, cardiovascular, COPD, and neurological condition management.
Medication management
Smart dispensers, dosage calculation, and interaction and adverse-reaction tracking.
Digital therapeutics & IVD
Software-delivered therapy and lab-connected result interpretation and QA.
Standards Our Medical Device Software Development Services Meet
Every phase of our lifecycle produces the evidence your submission requires. We engineer against the standards below and prepare the documentation your regulatory team needs for clearance.
| Standard / regulation | What it governs | How Ailoitte applies it |
|---|---|---|
| IEC 62304 | Medical device software lifecycle | We structure the full lifecycle, from planning and requirements to architecture, implementation, V&V, and maintenance, classified by software safety class A, B, or C. |
| ISO 14971 | Risk management for medical devices | We create and maintain the risk management file, linking hazards to controls and to verification evidence. |
| ISO 13485 | Quality management system | We work within your ISO 13485 quality system and provide the documentation it requires. |
| FDA (US) | 510(k), De Novo, PMA, 21 CFR Part 820, Part 11 | We produce submission-ready documentation, including the Design History File, and support your regulatory affairs team through clearance. |
| EU MDR & IVDR | Device and IVD market access in the EU | We prepare technical documentation for CE marking and notified-body review. |
| HIPAA · HITECH · GDPR | Protected health information and privacy | HIPAA-ready engineering with encryption, anonymization, access controls, and audit logging by default. |
| IEC 82304-1 · 60601-1 | Health software and electrical safety | Applied where product type and connected hardware require it. |
| HL7 · FHIR R4 · DICOM | Interoperability and clinical data exchange | Built in so your medical device software exchanges data cleanly across the clinical ecosystem. |
Ailoitte holds ISO 27001, ISO 9001, and SOC 2 Type II certifications and builds to IEC 62304 and ISO 14971. We support your organization's ISO 13485 quality management system with the documentation it requires.
Our Medical Device Software Development Process
Our medical device software development process is mapped to IEC 62304 and ISO 14971. Each phase produces documentation that supports your regulatory submission.
Discovery & classification
Define intended use and users; classify the software as SaMD or SiMD and set the device class and IEC 62304 safety class.
Requirements & risk planning
Capture and prioritize requirements and open the ISO 14971 risk file and risk management plan.
Architecture & UX/UI design
Design a scalable, configurable architecture and a clinically usable interface for all levels of tech literacy.
Development
Cross-platform engineering with secure coding, EHR and device integration, and continuous traceability.
Verification & validation
Multi-level testing from unit to validation, with V&V and code reviews and requirement-to-test traceability.
Premarket submission support
Design History File, risk file, and documentation for FDA 510(k), De Novo, PMA, and CE marking.
Device & IoMT integration
Stable connectivity with wearable and non-wearable devices and analytics on patient-generated data.
Post-market support
Monitoring, security patching, change control, and feature evolution that preserve compliance.
HIPAA-ready from the very first screen
Consent, encryption, and access control are engineered into the product, not added before an audit. Patients see exactly how their data is handled, and your compliance team gets the records to prove it.
- Clear, informed consent flows built into onboarding
- End-to-end encryption, anonymization, and audit logging by default
- HIPAA-ready practices backed by ISO 27001 and SOC 2 Type II discipline
Technologies for Medical Device Software Development
A stack chosen for connectivity, security, and interoperability across connected devices and SaMD.
Healthcare & Connected-Care Software We've Shipped
Our healthcare portfolio spans connected care platforms, HIPAA-compliant telehealth, and companion apps for connected health devices, the same engineering foundations our medical device software development services are built on.
AssureCare
A connected, patient-centered care platform with EHR and care-management modules (MedCompass, iPatientCare) delivering end-to-end care management to millions of members daily for leading commercial and government payers.
Mindfully
A HIPAA-compliant mental health platform with encrypted video therapy, real-time booking, and provider dashboards for clinical notes and patient records, serving over 12,000 clients annually across multiple states.
Dr. Morepen
A health and wellness companion app for a maker of connected home-health devices, integrating device tracking tools and educational content to put "Health in Your Hands" for everyday users.
Explore the full healthcare portfolio, including connected care, telehealth, and EHR builds.
View all healthcare workReviewed by our clinical and regulatory team
Our medical device software development services are reviewed by experienced regulatory and quality specialists to ensure every deliverable meets the safety, documentation, and compliance standards the healthcare industry requires, before it reaches verification or submission.
What Medical Device Software Development Costs
The cost of medical device software development services is driven by functional scope, the number and complexity of device integrations, device safety class, compliance requirements, and delivery scope, whether that is a proof of concept, an MVP, or a full product.
Fixed price
Best when scope is stable. Pre-agreed quote with payments tied to milestones.
Time & materials
Best when scope will evolve. Monthly reporting and billing against real progress.
AI Velocity Pods
Fixed-price, outcome-based delivery from a dedicated pod, accelerated by AI-native engineering without loosening controls.
Dedicated team / augmentation
Extend your engineering with regulated-healthcare specialists who work within your process.
Every device program is different. Share your intended use, device class, and target markets, and we will return a scoped estimate.
Request a Scoped EstimateWhy Teams Choose Our Medical Device Software Development Services
Compliance built in
An IEC 62304 lifecycle, ISO 14971 risk management, and submission documentation produced from day one, not bolted on at the end.
Faster, safe delivery
AI-native engineering and AI Velocity Pods speed delivery without loosening the controls a regulated device demands.
Connected by default
Native FHIR, HL7, and DICOM plus IoMT connectivity so your software fits the clinical ecosystem.
Security-first
HIPAA-ready practices backed by ISO 27001 and SOC 2 Type II engineering discipline.
Proven at scale
300+ products delivered across 21 countries, with 50M+ downloads across the applications we have engineered.
No vendor lock-in
Documented code, tests, and knowledge transfer, so you stay in control of your product.
Medical Device Software Development Services: Questions
Ready to build safe, submission-ready medical device software?
Tell us about your device, intended use, and target markets. We will map the standards that apply and return a scoped plan for your medical device software development services.
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