Blog /Healthcare Medical Device Software Development Cost: How the IEC 62304 Class Sets Your Budget Published byGroovy Web Team Published: Nov 13, 2026 Time to read: 8 min read Add as a preferred source on Google What drives medical device software cost: the IEC 62304 safety class, the FDA documentation level, the quote lines to demand and the FDA fees that sit outside the build. Summarize with AI ChatGPT Claude Perplexity Grok Gemini What Decides the Cost of Medical Device Software? Two things set most of the cost: the IEC 62304 safety class of your software and the FDA documentation level your submission needs. They decide how much design, testing and paperwork you pay for on top of the code itself. Groovy Web builds software for regulated healthcare products from Nadiad, Gujarat. See our medical device software development work, or first use the three question test for SaMD vs embedded software to classify your product. This guide shows how each level changes the budget, which cost lines a fair quote should show, and which FDA fees sit outside the development budget. How Does the IEC 62304 Safety Class Change the Budget? IEC 62304 is the standard for medical device software life cycle processes. It sorts software into three safety classes by what a failure could do to a person, and the class sets how much work you owe. ClassIf the software failsWhat the work adds ANo injury or damage to health is possibleA defined process, with the least prescriptive requirements BInjury is possible, but not serious injuryDocumented requirements, architectural design and unit testing CDeath or serious injury is possibleThe full standard: detailed design, unit verification, integration and system testing, with every step traceable These class definitions and activity lists follow Greenlight Guru's guide to IEC 62304 software safety classes. The same guide notes that the class also affects risk management, configuration management and problem resolution, not only development. In practice, each step up the classes adds design records, test evidence and review time. That effort is the main reason two apps with similar screens can have very different quotes. What Do the FDA Documentation Levels Add? The FDA's guidance on the content of premarket submissions for device software functions, issued on June 14, 2023, recommends one of two documentation levels. Enhanced applies when a software failure could create a hazardous situation with a probable risk of death or serious injury. Basic applies in all other cases. The two levels differ in what you hand to the FDA, which changes how much you must write and test before you file. ItemBasicEnhanced Risk management file and requirements specificationIncludedIncluded Software design specificationNot recommended in the submission, kept in the design history fileIncluded Testing evidenceSummary of unit, integration and system testingUnit and integration test protocols with expected results, observed results and pass or fail calls Development and maintenance recordsSummary of the plan, or a declaration of conformity to IEC 62304The Basic items plus complete configuration management and maintenance plans The FDA also says it generally recommends Enhanced documentation for Class III devices and for devices that are a constituent part of a combination product. A sponsor can ask for feedback on its documentation level through a Pre-Submission before filing. Which Cost Lines Should a Quote Show? A single day rate hides where the effort goes. Ask any vendor to price these lines separately, so you can see what each class and documentation level adds. Product definition and software requirements, including intended use Architecture and design records Build and code review Verification: unit, integration and system testing Risk management file, kept current as the design changes Cybersecurity design and testing Traceability and configuration management Change control and maintenance after release If a quote shows only "development" and "testing", you cannot tell whether it covers the evidence your class needs. Ask what happens to the price when the class changes. What Do FDA Fees Add on Top of Development? FDA fees are not part of the software build, but they belong in the launch budget. The FDA publishes the fiscal year 2027 amounts, which apply from October 1, 2026 to September 30, 2027, on its medical device user fee page. FeeStandardSmall business 510(k) premarket notification$28,653$7,163 De Novo classification request$191,020$47,755 PMA application$636,732$159,183 Annual establishment registration$13,785Waiver possible on hardship Your regulatory pathway decides which fee applies, and small business status must be confirmed with the FDA each year. Treat these as separate from, and in addition to, the cost of building the software. Does SaMD or Embedded Software Cost More? Neither one is always cheaper. Cost follows the safety class and the documentation level far more than it follows the label. A Class A app can cost less than a Class C firmware module, and a Class C diagnostic app can cost more than both. The two paths differ in where the effort lands. Embedded work adds hardware cycles and field update planning, while SaMD adds clinical evidence, cybersecurity and data handling. Our guide to SaMD vs embedded medical device software shows how to tell which one you are building. How Can You Plan the Budget Without Cutting Corners? Start by writing your intended use in one sentence, because the class and the documentation level both follow from it. Then ask your regulatory lead for the class and the documentation level before you ask any vendor for a price. Use the FDA Pre-Submission route if the documentation level is unclear, since the FDA says sponsors may request feedback on it before filing. Fixing the level before the build starts is cheaper than rewriting records after the design is frozen. Which Budget Plan Fits Your Product? Choose a Class A plan if: - A software failure cannot cause injury or damage to health - Your regulatory lead has confirmed Basic documentation - You want a defined process without the full design and test evidence set Choose a Class B plan if: - A failure could cause injury, but not serious injury - You can document requirements, architecture and unit testing from the start - You expect Basic documentation, and your regulatory lead agrees Choose a Class C and Enhanced plan if: - A failure could cause death or serious injury - You need traceable design, unit, integration and system testing - You will provide test protocols and maintenance plans in the submission Bottom line: Confirm the safety class and the documentation level first, then ask for a quote with separate lines for design, testing, risk and cybersecurity work. Add FDA fees as their own line. A price that ignores your class is a guess. FREE · 30 MINUTES · NO OBLIGATION Get a free medical software scoping review Tell us what your product does and who uses it. A senior engineer will help you check the software class and plan the build. Request my free review No sales pitchBuilt for teams planning medical device softwareReply within 1 business day Frequently Asked Questions How much does medical device software development cost? It depends on the IEC 62304 safety class, the FDA documentation level and the scope of the product, so no honest single number fits every project. Ask for a quote that prices design, build, verification, risk and cybersecurity work as separate lines. Does a higher IEC 62304 class cost more? Yes, usually. Class C requires the full set of life cycle activities, including detailed design and integration and system testing, with every step traceable. Class A is the least prescriptive, so it asks for less evidence. What is the difference between Basic and Enhanced documentation? Enhanced applies when a software failure could create a hazardous situation with a probable risk of death or serious injury. It adds the software design specification and unit and integration test protocols to the submission. Basic covers all other cases. Do FDA fees count as part of the software budget? No. They are separate regulatory fees that depend on your pathway, such as 510(k), De Novo or PMA. Plan for them in the launch budget next to development, and check the current fiscal year amounts on the FDA's fee page. Is SaMD cheaper to build than embedded software? Not by default. Cost follows the safety class and documentation level more than the label. SaMD often ships updates faster, while embedded work adds hardware cycles, so compare the two with your own class and scope. Can an India-based team build regulated medical software? Yes, if the team works inside your quality system and keeps the records the standards require. Ask for sample documentation, named engineers and data location terms before you sign. Want a Budget That Shows Where the Effort Goes? Groovy Web builds software for medical device teams and can scope the work once your safety class is clear. Tell us what the product does and we will tell you what to confirm before you ask for prices. Request a Quote → Related Services Medical Device Software Development Healthcare Software Development Further Reading How to Tell SaMD From Embedded Medical Device Software How Healthcare App Compliance Works What HIPAA Means for AI in Healthcare How EMR Integration Works Ship Production-Grade AI with Senior Engineers Our AI-First engineering approach delivers production-ready applications in weeks, not months. Hire an AI-First Engineering Team Was this article helpful? Yes No Thanks for your feedback! We'll use it to improve our content. 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