Medical Device Software Development: SaMD, Embedded and Connected Device Software Built Inside Your Quality System

Updated October 2026 · Written and maintained by the Progression Agency strategy team

Medical device software development is the design, coding, testing and documentation of software that is itself a medical device, or that runs inside or alongside one, under a life cycle a manufacturer can defend to FDA and other regulators. Software development for medical devices differs from ordinary product work because every requirement, risk control and test has to be traceable, the level of rigor follows the software’s safety class, and the manufacturer, not the developer, owns the quality system and the submission. This page covers when software counts as a medical device, the medical device software we build, the IEC 62304 life cycle, what FDA’s device software guidance asks for, risk management, testing and verification, cybersecurity, integrations and what the work costs. We build medical device software for manufacturers and digital health companies inside their quality system, starting with a free proposal and a written scope.

What is medical device software development?

Medical device software development is software engineering done to the standard that a medical device demands. The code is only part of it. Each requirement is written so it can be tested, each hazard the software could cause is recorded with the control that addresses it, each test traces back to a requirement, and each release leaves a record. Medical device design and development in the wider sense also covers hardware, mechanical and clinical work; this page is about the software inside that program, and about software that is a device by itself.

Our software development company page describes how we build custom software in general. Regulated device software adds a life cycle, a quality system and a documentation burden on top.

Who this page is for

Four kinds of organization commission this work:

• Device manufacturers that need software for a new product, or a rebuild of software that has outgrown its first version.
• Software as a Medical Device startups that are building the product itself and need a team that works to a documented process.
• Device makers adding an app, a cloud or an integration to hardware they already sell.
• Contract manufacturers and design houses that need a software partner for a client’s program.

What we build and what stays with you

We write and document the software. You own the quality management system, the regulatory strategy, the submission and the decision about what the product is and how it is classified. We work inside your process and supply the records it asks for. We do not certify products, hold certifications for you or decide a regulatory question. The same split is described on our embedded software development page, which covers firmware.

Medical device software we build

Medical device software takes several forms, and each form has its own team shape and its own questions. Non-device health software, such as scheduling, billing or records tools, belongs on our healthcare software development page; the sections below cover the software that is a device or sits inside one.

Software as a Medical Device (SaMD)

FDA’s page on the topic says Software as a Medical Device is one of three types of software related to medical devices, and quotes the International Medical Device Regulators Forum definition: software intended to be used for one or more medical purposes that perform those purposes without being part of a hardware medical device. SaMD development therefore means a full product built as software: the algorithm or function, the interface, the cloud and the update mechanism, all under the same life cycle.

Software in a medical device (SiMD) and device firmware

The second type on FDA’s list is software that is integral to a medical device, often shortened to SiMD. This is firmware, control software and the code that runs on the device’s processors. Our embedded software development team writes it, and this page covers the life cycle that surrounds it.

Medical device app development: companion and patient apps

A companion app pairs with a device to show readings, set options or send data; a patient app may deliver a medical function of its own. Medical device app development has to settle the same questions as any device software, plus phone operating system updates, app store review and the privacy rules for health data. Our healthcare app development page covers health apps more broadly.

Device clouds, dashboards and data platforms

Connected devices send data to a cloud that stores it, analyzes it and shows it to clinicians or patients. These back ends are part of the product, and their changes need the same traceability as the device. Our remote patient monitoring software development page covers monitoring platforms.

Manufacturing, test and service software

FDA’s SaMD page lists a third type: software used in the manufacture or maintenance of a medical device. Production test stations, line software and service tools fall in that category. Our manufacturing software development page covers that work.

When software is a medical device: SaMD, SiMD and device software functions

Is software a medical device? Sometimes, and the answer depends on what the software is intended to do. FDA’s policies on device software are function-specific and apply across platforms, so the same code on a phone, a server or inside a hardware device is judged by its function. When software is considered a medical device is therefore a question for the manufacturer and its regulatory advisers, working from FDA’s own pages rather than from this one. The three boxes below restate what those pages say; they are not a determination for any product.

The SaMD definition FDA uses

On its Software as a Medical Device page, FDA says SaMD is one of three types of software related to medical devices and quotes IMDRF’s definition. The page adds that SaMD can run on a range of platforms, including commercial off-the-shelf computers and virtual networks, and was once called standalone software or health software. The other two types are software in a medical device and software used to make or maintain one.

Device software functions, enforcement discretion and non-device software

FDA’s page on device software functions says the agency takes a risk-based approach, focusing on the subset of software functions that meet the definition of a device in section 201(h) of the Federal Food, Drug, and Cosmetic Act and that pose greater risk to patients if they fail. For many functions that are devices but pose minimal risk, it says it will exercise enforcement discretion; it gives as examples functions that help patients self-manage a condition without specific treatment suggestions and functions that automate simple tasks for providers. It also says the 21st Century Cures Act removed certain software functions from the device definition. The matching guidance is the Policy for Device Software Functions and Mobile Medical Applications. Software for drug makers and biotech companies sits under different rules, which our pharmaceutical software development page covers.

Clinical decision support software

FDA’s guidance on Clinical Decision Support Software explains which decision support functions are excluded from the device definition under the criteria in section 520(o)(1)(E) of the FD&C Act, and says FDA’s digital health policies continue to apply to software functions that meet the device definition, including those intended for patients or caregivers. The page showed content current as of January 29, 2026. Whether a particular feature meets those criteria is a question for the manufacturer and its regulatory advisers, and nothing here answers it.

Is a mobile app a medical device?

FDA’s page says mobile medical apps are mobile apps that incorporate device software functionality meeting the device definition and that are either an accessory to a regulated medical device or turn a mobile platform into a regulated device. Apps that only help people manage general health and wellness are a different case, and FDA invites developers to ask it early if they are unsure. The manufacturer decides, with its advisers, from the app’s intended use.

Software development for medical devices, step by step

Software development for medical devices is ordinary engineering with extra memory: the project has to remember why each decision was made. The steps are familiar, but each one leaves a record that someone can audit years later.

Medical device software engineering roles on a project

Medical device software engineering is a team activity with named roles. Someone owns requirements and traceability, someone owns architecture, developers write and review code, test engineers write protocols and run them, and a person on the client’s side owns risk management and the quality system. Under the split described above, risk management and the quality system stay with the manufacturer, and the records from the other roles feed into them.

Traceability from requirement to test result

Traceability means a reviewer can start at a requirement and find the design, code and tests that implement and check it, and start at a test result and find the requirement behind it. FDA’s guidance on premarket submissions describes traceability checks between requirements, design, source code and test cases. Tooling helps, but the discipline matters more: no requirement without a test, no test without a requirement.

Architecture and SOUP decisions

Most device software includes outside components: operating systems, libraries, protocol stacks and open-source packages. IEC 62304 has requirements for specifying the function and performance of such items and the system hardware and software they need, under its term SOUP. Good architecture limits how many outside items there are, isolates them behind interfaces and records the version and the reason for each. FDA’s premarket guidance also says it may ask for additional information when a device uses off-the-shelf software, and mentions a software bill of materials as one way to list components.

Releases, versions and change records

A release is a claim: this build contains these changes, was made from these sources and passed these tests. A release record states it. FDA’s premarket guidance lists a software version history among the documentation elements, and the same habit supports internal audits. Version numbers, tags and change records should make the history readable without the original developers.

The medical device software development life cycle

The medical device software development life cycle is the sequence of planning, requirements, design, implementation, verification, release and maintenance, with risk management running through all of it. The standard that describes it is covered in the IEC 62304 section below. Our software development life cycle page covers life cycle models in general.

Planning: the software development plan

A medical device software development plan says how the work will be done: the activities, the deliverables, the tools, the roles, the verification approach and how changes are controlled. Software development plan medical device teams usually write it first, review it with the quality owner and revise it when the project changes. FDA’s premarket guidance asks for a summary of the life cycle development plan or, as an alternative, a declaration of conformity to the FDA-recognized version of IEC 62304.

Agile medical device software development

Agile medical device software development is possible and common, provided the sprints sit inside a documented process. Short iterations, continuous integration and frequent reviews can coexist with a plan, requirements reviews and a release record. What changes is that each sprint’s output includes its tests, its traceability and its updated risk inputs, so nothing has to be reconstructed at the end.

Maintenance and problem resolution after release

Software does not stop when it ships. Problems reported from the field need to be logged, analyzed for safety impact, fixed and released through the same controlled process. The IEC description says the standard covers development and maintenance of medical device software, and FDA’s guidance asks about maintenance activities. A maintenance plan written before launch saves a scramble when the first report arrives.

What FDA expects from medical device software

FDA medical device software guidance is spread across several documents, and this section walks through three that matter to a development team. The guidance mostly describes what a sponsor submits, so the developer’s job is to produce the evidence the manufacturer will use. Medical device software compliance is likewise the manufacturer’s responsibility; a developer supports it with records. For wording on what a product may be called, see our medical device marketing page.

Content of premarket submissions for device software functions

FDA’s guidance on the content of premarket submissions for device software functions (content current as of June 14, 2023) gives recommended documentation for device software functions and replaces the 2005 guidance on software contained in medical devices. It sets two documentation levels. Enhanced Documentation applies where a failure or flaw of a device software function could present a hazardous situation with a probable risk of death or serious injury, judged before risk controls; Basic Documentation applies otherwise. The recommended elements include a software description, a risk management file, a software requirements specification, a system and software architecture diagram, a software design specification, a description of development, configuration management and maintenance practices, software testing as part of verification and validation, a software version history and a list of unresolved anomalies.

The Quality Management System Regulation since February 2, 2026

FDA says the Quality Management System Regulation became effective on February 2, 2026. It amends the device quality requirements in 21 CFR Part 820 and incorporates ISO 13485:2016 by reference, and it applies to finished device manufacturers. Read FDA’s QMSR page and the regulation in the eCFR. We work inside our clients’ quality systems; we hold no ISO 13485 registration and make no claim about one.

Software validation guidance from 2002, and what it still covers

FDA’s General Principles of Software Validation, issued in January 2002, applies to software used as a component, part or accessory of a medical device, to software that is itself a device, to software used in producing a device and to software used to implement a manufacturer’s quality system. It recommends verification and validation activities throughout the software life cycle and does not recommend a particular life cycle model. It also says that when the software is developed by someone other than the device manufacturer, the manufacturer, which holds the regulatory responsibility, needs to assess the adequacy of the developer’s activities.

IEC 62304 medical device software: classes, records and the process

IEC 62304 is the international standard that defines life cycle processes for medical device software, and IEC 62304 software work produces a trail of records. This section restates what the IEC and FDA publish about it. It does not quote the standard, which is sold by the IEC, and it does not tell you what your product requires.

What does IEC 62304 require?

It sets requirements for a software life cycle. The clauses named in FDA’s premarket guidance and in the IEC subcommittee’s change rationale include software development planning, verification planning, risk management planning, documentation planning, requirements, a maintenance process and a configuration management process. The detail sits in the standard itself, which the IEC sells, so this page does not reproduce it. The next section restates the IEC’s own description.

What IEC 62304 covers

The IEC’s webstore description says IEC 62304 defines the life cycle requirements for medical device software, through a set of processes, activities and tasks that make a common framework. It applies to the development and maintenance of medical device software when the software is itself a medical device or is an embedded or integral part of one. It does not cover validation and final release of the device, even when the device is entirely software. The consolidated version combines the first edition of 2006 with Amendment 1 of 2015, and the webstore lists a stability date of 2028.

Software safety classification

The standard’s first edition sorts software into three safety classes, A, B and C, and the classification drives how much process rigor is applied. IEC 62304 software safety classification is the manufacturer’s decision, made from its risk analysis, and a project plan should state the class and the reasoning. A committee draft of a second edition proposes changes to this scheme; the IEC subcommittee’s change rationale explains them.

IEC 82304 vs IEC 62304

The two standards answer different questions. The IEC describes IEC 82304-1:2016 as applying to the safety and security of health software products designed to run on general computing platforms and sold without dedicated hardware, with the primary focus on manufacturers and the whole product life cycle. IEC 62304 describes the software life cycle processes for medical device software. The descriptions point at different things: one at health software products as a whole, the other at the life cycle processes for medical device software. Read the IEC 82304-1 listing and decide with your regulatory advisers which applies.

FDA recognition of IEC 62304

FDA lists IEC 62304 as a recognized consensus standard, recognition number 13-79, recognized as a complete standard; its recognition entry shows an entry date of January 14, 2019 and names FDA’s premarket submission and software validation guidance among supporting publications. FDA’s premarket guidance lets a sponsor provide a declaration of conformity to the recognized version for certain life cycle practices.

The IEC 62304 checklist: records a project keeps

The IEC 62304 checklist below names the records a team keeps for software under this life cycle. Which ones your project needs, and in what depth, depends on the plan and the safety class; this list names them and does not rate them.

Risk management for medical device software

Risk management for medical device software starts from a simple question: what could go wrong because of this software, and who could be hurt? FDA’s premarket guidance lists ISO 14971, the device risk management standard, among the standards it harmonized with, and treats the risk management file as a documentation element. The manufacturer owns the risk file; the developer feeds it.

Who owns the risk file on a joint project?

The manufacturer does. FDA’s software validation guidance says that when software is developed by someone other than the device manufacturer, the manufacturer, which holds the regulatory responsibility, needs to assess the developer’s activities. A developer feeds the file with hazards found during design and with evidence that controls work; the manufacturer’s risk lead decides what is acceptable.

Hazards a software failure can cause

Software can contribute to harm in several ways: a wrong result displayed, a right result displayed late, an alarm that does not sound, a dose or setting changed by mistake, data attached to the wrong patient, or a device left unusable by a failed update. A hazard analysis written with clinicians and the manufacturer’s risk lead names these in plain language before they become requirements.

Risk controls in code, design and labeling

A risk control may be a requirement in software, a design choice such as an interlock, a check on input, a limit on a range, or a warning in the labeling. Software controls become requirements that are tested. FDA’s guidance asks sponsors to judge the documentation level from hazards assessed before risk controls are applied, which is why the original hazard analysis matters.

Keeping the risk file and the code in step

Risk files rot when the code changes and the file does not. Each change request should ask whether it touches a hazard, a control or a requirement that implements one, and the answer should be recorded. FDA’s guidance also tells sponsors to consider the likelihood that functionality is compromised by inadequate cybersecurity when they judge risk.

Medical device software design and usability

Medical device software design is judged by whether the right person can do the right thing quickly and correctly under pressure. Software design for medical devices therefore treats the screen as a safety feature, not as decoration. Our UI and UX design services page covers interface design in general.

Designing screens clinicians and patients will not misread

Use plain labels, consistent units, clear states and confirmation for actions that change therapy. Test screens with representative users, including people who will see the software for the first time, and record what the tests show. A screen that is easy to misread is a hazard to put in the risk file.

Alarms, alerts and notification fatigue

Alerts that fire too often teach people to ignore them. Decide which events need an alarm, which need a quiet message and which need none, set priorities, and make the behavior testable. Where an alert is a risk control, say so in the requirement so no one removes it as noise.

Accessibility for home-use software

Home-use devices are operated by people with a wide range of eyesight, dexterity, language and experience. Large touch targets, readable contrast, plain language and support for screen readers help all of them. These are design requirements and belong in the same traced list as any other.

Medical device software integration: EHRs, devices and the cloud

Medical device software integration connects the product to the systems around it. Each connection is a separate interface with its own tests, its own failure cases and its own hazards.

HL7 v2 and FHIR

Hospitals and clinics exchange data with other systems through standard message and API formats, and HL7 version 2 and FHIR are two such formats. We build and test the interfaces and document the mapping from device data to the fields on the other side. Our healthcare software development page covers EHR work in more depth.

Bluetooth, cellular and device gateways

Devices reach phones and clouds over Bluetooth Low Energy, Wi-Fi or cellular links, often through a gateway or hub. Each link adds failure modes: dropped connections, duplicate messages, stale data. Our embedded software development team builds the firmware side, and the app and cloud sides are tested against it.

Does a companion app need the same process as the device?

That depends on what the app does. If it performs a device function, it falls under the same life cycle and records; if it only displays non-device information, the manufacturer may treat it differently. The manufacturer decides, and we can run the same traced process for both so the choice does not slow the project.

Data that leaves the device: privacy and HIPAA where it applies

When data leaves a device it may become protected health information, depending on who holds it and why. HIPAA applies to covered entities and their business associates, as defined in 45 CFR 160.103, and the manufacturer’s counsel decides whether a given product is in scope. We build the access controls, logging and data handling to the requirements the client sets; our healthcare app development and HIPAA compliant software development pages describe that work.

Medical device software testing, verification and validation

Medical device software testing is the evidence that the software does what its requirements say. Medical device software verification and validation are related but different activities, and medical device software validation as a whole includes the device and its users, not only the code. FDA’s General Principles of Software Validation recommends that verification and validation activities run throughout the software life cycle.

Unit, integration and system testing

Unit tests check the smallest pieces, integration tests check that the pieces work together and system tests check the requirements of the whole. Each test has an identifier, a link to a requirement, a procedure and a recorded result. Static analysis, code review and coverage measurements back the tests.

Verification versus validation: who does which

Verification asks whether the software was built right: does it meet its requirements? Validation asks whether the right thing was built: does the finished device meet the user’s needs in its intended use? We run software verification. The manufacturer runs device validation, including use in the intended setting, because it holds the regulatory responsibility; the IEC description says IEC 62304 itself does not cover the device’s validation and final release.

Automated test evidence that survives an audit

Automated tests are only evidence if the results are kept. Run them in a pipeline that records the build, the test version, the environment and the outcome, and archive the records with the release. An auditor can then see not only that tests exist but what ran against which build.

Cybersecurity in medical device software

A connected device is a computer on a clinical network, and its software has to be designed with that in mind. FDA’s cybersecurity premarket guidance (page current as of February 3, 2026) gives recommendations on cybersecurity design, labeling and the documentation to include in premarket submissions for devices with cybersecurity risk, and addresses section 524B of the FD&C Act for cyber devices. Our embedded software development page goes through FDA’s cybersecurity expectations for connected devices in more depth.

Threat modeling and an SBOM from the first sprint

Threat modeling asks how an attacker could reach the device, the app or the cloud, and what they could do. It is cheaper in the first sprint than the last. A software bill of materials lists the components in the product; FDA’s premarket guidance on device software functions describes one as an example way to list software components, including open source and off-the-shelf ones. We generate and maintain one from the build.

Patching and coordinated disclosure after release

Vulnerabilities will be found after launch. The software needs a way to ship patches safely, and the manufacturer needs a published way for researchers to report problems and a process to assess them. We build the update mechanism and support the process; the manufacturer owns the disclosure policy.

AI and machine learning in device software

Models inside device software raise extra questions about data, change and monitoring. FDA has published a draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (page current as of January 7, 2025), on the contents of marketing submissions for devices with AI-enabled software functions and on design and development practices across the total product life cycle. We build the data pipelines, model serving, version control and monitoring around a model; the manufacturer and its regulatory advisers decide how the guidance applies to the product.

Your quality system, our records

The quality system is yours, and the records are ours to produce inside it. That split is stated openly at the start, because the opposite assumption causes most supplier disputes in regulated software.

Records we hand over

The records we can hand over with each release include:

• The software development plan and its updates.
• Requirements, with identifiers and links to risks and tests.
• Architecture and design documents, and the list of outside software items.
• Test protocols, results and the traceability matrix.
• The software bill of materials and release notes.
• Problem reports and how each was resolved.

Audits and supplier controls

A manufacturer is expected to control its suppliers. We accept supplier quality agreements and supplier audits, and we answer an auditor’s questions about how the work was done and where the records are kept.

What we do not claim

We hold no ISO 13485 registration, we certify no software and no product, and we do not run validated systems for clients. We do not describe any product as cleared, approved or compliant on a manufacturer’s behalf, and we do not decide a product’s classification. Those belong to the manufacturer, its notified or regulatory bodies and its regulatory advisers.

Medical device software development services

Medical device software development services range from a single module inside a program to the whole software side of a product. The cards below name the work; a proposal says which parts you need.

• Planning and requirements: the development plan, requirements and traceability from the first sprint.
• Architecture and design: structure, interfaces and the choice of outside components.
• Implementation: firmware, apps, back ends and tooling, with reviews.
• Verification: test protocols, automation and recorded results.
• Release and maintenance: release records, patches and problem resolution.

How much does medical device software development cost?

Medical device software development cost depends on the safety class, the number of integrations, the amount of documentation and the size of the verification effort. The same feature costs more under a documented life cycle than outside one, because each requirement carries a design, a test and a record.

Our prices

Medical device software builds are quoted after a written scope. We publish no Progression project price, day rate or hourly rate for them, and a free proposal comes first.

Published US price bands

Published figures describe what software developers charge in general, not a Progression quote and not a price for a medical device in particular:

How long does a medical device software project take?

No honest answer exists before the safety class, the integrations and the state of your quality system are known. We agree phases in the written scope and make no fixed promise in advance, and regulatory review time belongs to the regulator, not to the developer.

What raises the cost: safety class, integrations and documentation

A higher safety class means more design, more verification and more records. More integrations mean more interfaces to build and test. And the depth of documentation your submission needs sets how much of each sprint goes to records rather than code. A written scope that states all three shrinks the range.

• Safety class and the documentation level that follows from it.
• Integrations with EHRs, devices, clouds and third-party services.
• The amount of verification evidence the submission and audits need.
• Platforms: one app or several, and the hardware the software runs on.

How to choose a medical device software development company

A medical device software company should show how it works inside your quality system before it shows a portfolio. Ask these questions of any medical device software development company, including us, and of any set of medical device software developers you are considering.

Questions to ask before you sign

Six questions separate firms that have worked under a quality system from those that have not:

Red flags

A few answers should end the conversation:

• A claim that the firm’s software is certified, cleared or validated, when only a manufacturer’s finished device or process can be.
• No traceability tooling, or a promise to reconstruct it at the end.
• No answer to how outside components are tracked.
• Unwillingness to sign a supplier quality agreement or accept an audit.
• A fixed price quoted before anyone has asked about the safety class.

Getting started

Three steps get a project moving, and none of them commits you to build.

1. Send us what the software does, its likely safety class, the hardware or platform it runs on and where your quality system stands.
2. We review it and return a free proposal with a written scope that names the work, the records and the phases.
3. You decide whether to start with an assessment of existing software, a first phase of new work, or both.

More pages on the services around medical device software:

• Embedded software development
• Healthcare software development
• Healthcare app development
• Remote patient monitoring software development
• Medical device marketing
• Manufacturing software development
• Software development company

Frequently asked questions