Medical Device Software Development Services

Medical Device Software Development: SaMD, FDA Classes, and the Engineering Process

A glucose sensor sends a reading to a phone app at 3 a.m. The app flags a dangerous drop, alerts a caregiver, and logs the event to the patient’s electronic health records before breakfast. Every step in that chain is medical device software, and every step has to work the same way on the thousandth night as on the first.

Regulators are seeing more of this software than ever. The FDA authorized a record 331 AI-enabled devices in 2025 and has cleared more than 1,400 since 1995, according to MedTech Dive’s tracker of the FDA list. For medical device manufacturers, digital health startups, and healthcare organizations, the takeaway is practical: software now decides how fast a product reaches patients and how well it holds up under regulatory review.

This guide explains what medical device software is, how Software as a Medical Device (SaMD) is defined and regulated, how FDA Class I, II, and III rules shape your project, and how a step-by-step engineering process takes a product from intended use to postmarket support. The final sections cover integration with existing health systems and the cost factors behind healthcare software projects.

What is Medical Device Software?

Medical device software is designed for medical purposes, such as diagnosing, preventing, monitoring, or treating diseases. In the United States, software meets the legal definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act when its intended use is medical. It can function independently or in combination with other medical devices, and it must comply with strict regulatory standards to ensure safety and efficacy.

Think of medical device software as the brain of modern medical devices. Just like how your brain processes information and helps you make decisions, this software analyzes data from medical devices and provides crucial insights to healthcare professionals.

For instance, it can help a doctor make an accurate diagnosis by interpreting the results from an MRI scan.

Medical device software is becoming increasingly popular and essential in modern healthcare due to its ability to enhance diagnostic accuracy, improve patient monitoring, and streamline treatment processes.

Healthcare firms slowly but surely adopt this advancement to provide personalized care and:

• Enhance patient care and safety through accurate diagnostics and monitoring
• Ensure compliance with regulatory standards, reducing legal and financial risks
• Improve operational efficiency by automating and streamlining clinical workflows
• Facilitate the integration of advanced technologies like AI and IoT into healthcare practices
• Provide scalable solutions that can evolve with technological advancements and healthcare needs

Three types of software in the medical device space

As the healthcare industry develops and medical devices get smarter and more intelligent, we underline three categories: embedded medical systems (also called software in a medical device, or SiMD), Software as a Medical Device (SaMD), and non-device healthcare software that supports care without being regulated as a device.

Embedded medical systems (SiMD)

Embedded medical systems are integrated within medical devices to perform dedicated functions, often critical to the operation of the device. These systems consist of hardware and software components designed to work seamlessly together to monitor, diagnose, and treat medical conditions.

Some examples of embedded systems in medical devices you’ll recognize include MRI and CT scanners. They use embedded device software to process and display detailed images of the body’s internal structures.

Other interesting examples include:

• Defibrillators: They monitor heart rhythms and deliver shocks if an abnormal heartbeat is detected, and blood glucose monitors provide real-time blood sugar levels for diabetes management
• Insulin pumps: These pumps continuously monitor blood glucose levels and adjust insulin delivery accordingly, helping patients manage their diabetes more effectively and with greater precision
• Fetal heart monitors: These monitors track a baby’s heart rate during pregnancy and labor, providing critical data to ensure the health and safety of both the mother and baby

Software as a Medical Device (SaMD)

Software as a Medical Device is software intended for one or more medical purposes that performs those purposes without being part of a hardware medical device. The definition comes from the International Medical Device Regulators Forum (IMDRF), and the FDA, the EU, and most major regulators use it as their reference point. For a plain-language introduction with examples, see our SaMD guide.

The key word is intended use. A heart-rate chart in a fitness app is wellness software. The same chart becomes SaMD the moment the app claims to detect atrial fibrillation. Your product claims, marketing copy, and user interface text all count as evidence of intended use, so regulatory strategy starts long before code review.

Demand is growing fast. Global Market Insights values the SaMD market at USD 5.8 billion in 2025 and projects USD 21.1 billion by 2035, with clinical decision support as the largest software segment.

How regulators rate SaMD risk

The IMDRF framework ranks SaMD on two questions. The first is how significant the information is: does the software treat or diagnose, drive clinical management, or only inform it? The second is how serious the healthcare situation is: critical, serious, or non-serious. A tool that diagnoses a critical condition lands in the highest category (IV). A tool that informs management of a non-serious condition lands in the lowest (I).

National regulators then map this logic onto their own classes. In the EU, Rule 11 of the Medical Device Regulation places most diagnostic and therapeutic software in Class IIa or higher. In the US, the FDA applies its three-class system, covered below.

Is your product SaMD? A quick check

• Medical purpose: Does the software diagnose, treat, mitigate, prevent, or monitor a disease or condition?
• No hardware dependency: Does it run on general-purpose computing platforms rather than controlling a specific device?
• Clinical claims: Do your labeling, website, or app store listing describe clinical outcomes?
• Clinician independence: Would a clinician rely on the output without being able to review the underlying logic? If so, the product is unlikely to qualify for the FDA’s non-device clinical decision support exemption

Two or more “yes” answers usually mean you need a regulatory assessment before development begins. Our healthcare software development services include this assessment during discovery.

FDA Medical Device Classification: Class I, II, and III

The FDA assigns every medical device, including SaMD, to one of three classes based on risk. Regulatory controls increase from Class I to Class III, and the class decides which premarket pathway applies, how much documentation you prepare, and how long review takes.

FDA class	Risk level	Controls	Typical pathway	Software examples
Class I	Low	General controls	Most are 510(k) exempt	Software that displays or stores device data without analysis
Class II	Moderate	General plus special controls	510(k), or De Novo when no predicate exists	ECG analysis apps, AI radiology triage, remote patient monitoring software
Class III	High	General controls plus premarket approval	PMA	Software that drives life-sustaining therapy, such as closed-loop insulin dosing

510(k), De Novo, and PMA pathways

• 510(k) premarket notification: You show that your device is substantially equivalent to a legally marketed predicate. Most Class II software, including the majority of AI-enabled devices, follows this route
• De Novo classification: For novel low- to moderate-risk devices with no predicate. A granted De Novo creates a new device type that later products can use as a predicate
• Premarket approval (PMA): The most demanding pathway, reserved for Class III devices. PMA requires valid scientific evidence, usually including clinical data, that the device is safe and effective

A Pre-Submission (Pre-Sub) meeting with the FDA before you file is one of the cheapest ways to reduce risk. You can confirm your class, predicate choice, and testing plan before the team builds against the wrong target.

Quality and software lifecycle standards

Three standards shape the engineering work regardless of class:

• IEC 62304: Defines the software development lifecycle and assigns safety classes A, B, or C based on the harm a software failure could cause. Class C software needs the deepest documentation, down to detailed unit design
• ISO 14971: Sets out risk management, from hazard identification to residual risk evaluation, across the whole product lifecycle
• ISO 13485: The quality management system standard. Since February 2, 2026, the FDA’s Quality Management System Regulation (QMSR) incorporates ISO 13485:2016 by reference, replacing the old Quality System Regulation

Connected devices face one more layer. Under section 524B of the FD&C Act, a “cyber device” submission must include a software bill of materials (SBOM), a plan to monitor and address vulnerabilities, and evidence of secure design.

Benefits of Medical Device Software Development

Medical device development is costly and time-consuming, so why do healthcare companies plan to develop custom medical device software? The myriad benefits of robust and reliable software for these critical devices make it worthwhile.

Enhanced patient care

Medical device software development directly improves patient care by providing precise, real-time data that aids diagnosis and treatment. For example, software in wearable devices can continuously monitor vital signs like heart rate and blood glucose levels, sending alerts to healthcare providers if something goes awry.

This kind of continuous monitoring can catch potential health issues early, allowing for quicker and more effective interventions, which leads to better patient outcomes.

Medical device software often includes patient management tools and patient data management features that help doctors and nurses keep track of patient histories, medication schedules, and treatment plans.

These features streamline communication and care coordination and ensure that everyone involved in a patient’s care is on the same page, reducing the chances of errors and improving overall patient outcomes. Patient engagement tools, such as reminders and secure messaging, keep patients involved between visits.

Improved operational efficiency

One of the most significant benefits of a medical device software project is its operational efficiency boost. By automating routine tasks such as data entry and patient monitoring, medical device manufacturers can significantly reduce the workload on healthcare professionals. This allows them to focus more on patient care and less on administrative duties.

Integrated health tech solutions can also streamline clinical and administrative workflows in hospitals and clinics. For instance, software that links different departments, such as radiology, lab services, and patient records, ensures that all necessary information is available instantly, eliminating delays and improving the speed and accuracy of medical services.

Regulatory compliance

Medical device software development also helps companies stay compliant with regulatory standards. Regulatory bodies like the FDA and the European Commission, through the EU Medical Device Regulation (MDR), have stringent requirements for medical devices, including software components

A well-designed software solution ensures that all aspects of the device meet these regulations, from data security to patient safety.

Compliance with these standards not only avoids legal troubles but also builds trust with users and healthcare providers. It assures them that the medical device has undergone rigorous testing and meets the highest safety standards, which is crucial for both market acceptance and patient safety.

Customization and scalability

Another significant advantage is the ability to customize and scale solutions to meet specific needs. Medical device software can be customized to fit the unique requirements of different healthcare settings, whether it’s a small clinic or an extensive hospital network.

This flexibility ensures the software can adapt to various workflows and patient management systems. Scalability is equally important, especially as medical technology evolves. As new features or updates are needed, scalable software can accommodate these changes without requiring a complete overhaul. Custom healthcare software development makes this possible because tailored healthcare software follows a clinic’s real processes instead of forcing staff into a generic template.

This future-proofs the investment and ensures that the medical devices remain up-to-date with the latest technological advancements.

Enhanced data security

Data security is especially essential in digital healthcare. The pressure is measurable: HIPAA Journal’s December 2025 report lists 697 large healthcare data breaches for 2025, each affecting 500 or more people. Medical device software projects prioritize protecting sensitive patient data and other health data from breaches and unauthorized access. Advanced encryption methods, secure access controls, and regular security updates are integral to these software systems.

By ensuring robust data security, medical device manufacturers protect patients’ personal information and build trust with healthcare providers. Secure software also helps in compliance with data protection regulations like HIPAA in the U.S. and GDPR in Europe, further safeguarding against potential legal issues. Patients also use digital healthcare services more confidently when they know their records are protected.

Innovation and competitive edge

Investing in medical device software development fosters innovation, giving companies a competitive edge. AI solutions for healthcare use machine learning to enhance diagnostic accuracy and treatment personalization.

For example, AI-powered software can analyze complex medical images and flag urgent findings for radiologists, which is why radiology accounts for the largest share of AI-enabled devices on the FDA’s list.

Staying at the forefront of technology not only attracts more clients but also positions the company as a leader in the healthcare sector. This reputation can lead to increased market share and opportunities for growth, making it a worthwhile investment for medical device manufacturers.

Integrating Medical Device Software with Healthcare Systems

A cleared device delivers little value if its data stays on the device. Integration connects device output to the healthcare systems clinicians already use, and each connection follows its own standard, from HL7 and FHIR for clinical records to DICOM for imaging. The table below lists the integrations we build most often.

System	Common standards	What integration enables
Electronic health records (EHR/EMR)	HL7 v2, FHIR R4, SMART on FHIR	Device readings flow into patient records automatically, with no manual data entry
Imaging systems (PACS, RIS)	DICOM, DICOMweb	AI results and annotated images return to the radiologist’s worklist
Connected devices and wearables	Bluetooth LE, IEEE 11073, MQTT gateways	Remote patient monitoring software collects vitals in real time
Practice management and billing	X12 EDI, vendor APIs	Monitoring time and device use feeds medical billing software and revenue cycle management.
Patient portals and engagement tools	FHIR APIs, OAuth 2.0	Patients see results, alerts, and care plans in one place
Analytics and data platforms	FHIR Bulk Data, ETL pipelines	Healthcare data analytics and predictive analytics across device fleets

EHR and EMR integration

EHR integration is usually the first request from healthcare providers. A FHIR-based interface lets device data land in the right patient chart with correct units, timestamps, and provenance. Clinical decision support tools can then read the same data and surface alerts inside the clinician’s existing workflow. The same approach connects remote patient monitoring systems, so readings taken at home reach the care team without manual uploads.

Legacy system modernization

Many hospitals still run legacy systems that predate FHIR. Our healthcare software developers build interface engines and adapters that translate between older HL7 v2 feeds and modern APIs, so you can modernize legacy healthcare systems in stages without disrupting existing medical systems or clinical workflows.

Secure data exchange

Every integration point is a potential attack surface. We protect sensitive patient data in transit and at rest with TLS, encryption, role-based access, and audit logging, and we design each interface to enable seamless data exchange without exposing more data than the receiving system needs.

How to Develop Medical Device Software: The Engineering Process Step by Step

Developing medical device software is a complex process that requires strict regulatory guidelines and rigorous testing procedures to ensure patient safety and product quality. The steps below follow the IEC 62304 lifecycle, so each one produces documentation your regulatory submission will need.

Here’s a step-by-step guide to help medical device manufacturers navigate this process:

1. Define intended use and regulatory strategy

Write a precise intended use statement first. That statement determines whether the product is SaMD, which FDA class and EU MDR class apply, and which pathway you will take. Settle the IEC 62304 safety class at the same time, because it sets the documentation depth for every later step.

2. Gather requirements and objectives

Next, you need to identify user needs and understand what they’re looking for in your software. Conduct surveys, interviews, and focus groups to gather detailed requirements.

This essential step helps set clear objectives, including specific functions, performance criteria, and compliance with regulatory standards.

4. Plan the architecture and design

In this stage, you need to develop a project plan and outline the timeline and milestones for the medical device software project. Include risk management plans and contingency measures.

Create a detailed software architecture that outlines how different components of the software will interact. This includes database design, user interfaces, and integration points with other systems.

5. Develop the software

After you build a prototype to visualize the design and gather feedback from stakeholders, it’s time to choose the right tools and tech stack. Select appropriate programming languages, frameworks, and development tools that align with your project requirements and regulatory standards.

Implement coding standards, version control, and continuous integration practices to ensure code quality and maintainability. Track every third-party library as SOUP (software of unknown provenance) with its version, known anomalies, and risk assessment; this list also feeds your SBOM.

6. Verify and validate

Once your development team has the software ready, it’s time to test and validate it. Test individual components of the software to ensure they work as expected. This includes both functional and non-functional testing.

Verify that the software’s different modules and components work together seamlessly. This is crucial for identifying issues when integrating various system parts.

Don’t forget about compliance testing. Ensure the software complies with all relevant regulatory standards and guidelines, such as ISO 13485, FDA, and EU MDR. Add usability validation under IEC 62366-1 and cybersecurity testing, including penetration tests, for any connected product.

7. Prepare the regulatory submission

Create detailed documentation covering all aspects of the software development process, including design, development, testing, and validation. This documentation is critical for regulatory submissions.

Submit the required documentation to relevant regulatory bodies for approval. This may include pre-market submissions, risk assessments, and clinical evaluations. For AI-enabled products, consider a Predetermined Change Control Plan (PCCP), which lets you update a model within agreed limits without a new submission each time.

8. Deploy, maintain, and monitor postmarket

Finally, approved software will need deployment and continuous maintenance. Ongoing support is necessary to address post-deployment issues, fix bugs, and ensure compliance with regulatory standards. Postmarket surveillance, complaint handling, and vulnerability monitoring continue for as long as the device is on the market.

Continuous maintenance is one reason many healthcare companies hire professional teams to develop custom medical device software. Thanks to their experience, they help maintain the software’s effectiveness and reliability.

What Drives Healthcare Software Development Costs for Medical Devices

Healthcare software development costs for a regulated product depend less on screen count and more on risk class and evidence. Teams that develop healthcare software for regulated use should budget for compliance work from the first sprint. Two apps with identical interfaces can differ several times in budget if one is wellness software and the other is Class II SaMD.

Cost driver	Why it changes the budget
FDA class and IEC 62304 safety class	Higher classes require more design documentation, traceability, and independent verification
Regulatory pathway	A 510(k) with a clear predicate costs less to prepare than a De Novo request or a PMA
Clinical evidence	Clinical validation studies for AI or diagnostic claims add time, data costs, and statistical work
Integrations	Each EHR, PACS, or billing integration needs its own interface, testing, and vendor coordination
Cybersecurity scope	Connected devices need threat modeling, an SBOM, penetration testing, and vulnerability monitoring
Postmarket support	Maintenance, updates, and surveillance continue after launch and belong in the total cost of ownership

Use our project cost estimator to get a figure based on your device class, integrations, and timeline.

Build Compliant Medical Device Software with Glorium Technologies

Choosing the right healthcare software development company is crucial for the success of your project. Glorium Technologies is a full-cycle app and software development company with 200+ skilled professionals, on the market since 2010, and a 99% client satisfaction rate. The company offers medical software development services and custom healthcare software solutions for SaMD, embedded, and non-device products, plus custom healthcare app development for patients and clinicians.

Our teams hold ISO 13485, ISO 9001, and ISO 27001 certifications and build HIPAA-compliant, HL7 FHIR-ready products for medical device manufacturers, healthcare providers, and digital health startups. These end-to-end healthcare software development solutions cover the full path, from intended use and risk analysis through development, verification, submission documentation, and ongoing support.

Contact us today and book a free consultation with our representative. Leverage our in-depth industry experience, custom healthcare solutions, and a user-centric approach.

Elevate your operations, innovate faster, & achieve outstanding results.

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