Medical software development process is how you run a medical-software project: requirements and an SRS you can trace, human factors as a chapter, FDA-grade coding, test and validate, then 510(k) or PMA as a step. It is generic healthcare SDLC. It is not the engineering discipline, not IEC 62304 Class A/B/C, and not device Phase 0–5.
If you meant the engineering discipline → healthcare software engineering. If you meant IEC 62304 / SaMD vs SiMD → medical device software development. If you meant device development process → medical device development process. If you meant software testing → medical device software testing. If you meant software validation → medical device software validation. If you meant FDA 510(k) → FDA medical device approval process.
If the software is a web DICOM viewer or imaging model, PYCAD is the imaging stack, not a generic medical-software process house.
Why this is not a consumer SDLC
A bug in a photo app is an annoyance. A bug in medical software can harm a patient. “Move fast and break things” does not apply. The rule is move deliberately and prove it. You are writing for a surgeon who needs the number now, an administrator who owns the breach, an FDA reviewer who will walk the file, and an IT group that still runs last decade’s interface.
Risk sets the rigor. A step-counter is light. Software that reads an MRI to diagnose, or that drives a radiation machine, is Software as a Medical Device — a label for the high-risk class, not a reason to paste IEC 62304 Class A/B/C onto this URL. That lifecycle is 700 6022. Device Phase 0–5 (concept through launch as a device) is 699 5711.
Requirements, SRS, traceability
Clinicians do not hand you a spec. “Make it more intuitive” might mean pre-op imaging, vitals, and labs on one screen — or buttons a gloved hand can hit. Shadow the floor. Walk a real case (“ER, symptoms X, show me every tap”). Put a wireframe in front of them; five minutes on a mock beats an hour of adjectives.
| Type | Who it comes from | What you write down | How you prove it |
|---|---|---|---|
| Functional | Clinicians, stakeholders | What the software must do, in the SRS | Use-case tests, UAT |
| Non-functional | IT, architecture | Performance, uptime, security | Load, security review |
| Regulatory | FDA / MDR / your QMS | The constraint, with an ID you can trace | The file. Missing IDs fail the audit. |
| UX / use | Observation, HFE | Wireframes, the use-related risk | Usability test, not a vibe check |
| Data | Interfaces, legacy | Dictionary, mapping | Integrity checks on the hop |
A one-click prescribe is a clinician want and a safety fail. The two-step confirm is the requirement. Write the “why” so the floor does not treat it as friction.
The SRS is for two readers: the developer who has to build it, and the auditor who has to follow it. Every requirement gets an ID. That ID walks through design, code, test, and the validation report. Break the chain and the file stops. This is generic medical-software requirements, not 62304-how-to — that page is 700.
Human factors, then the UI deep-dive
The interface is a safety control. A tired clinician at hour twelve will hit the wrong control if you hide it. Cut cognitive load: surface the new critical lab, not the entire history. Same red means the same thing on every screen. Irreversible acts get a confirm that states the dose, not a toast.
Design for the room you get — a dim bay, a small tablet on a pole, fluorescent glare — not the designer’s monitor. A keypad that turns “5.0” into “50” is a tenfold overdose with a UI as the cause.
That is the HFE chapter. The device-UI how-to is medical device user interface design (leftover 499). Do not grow a second 499 here.
Coding that survives a reviewer
The code has to be provably what you said it was. Defensive input handling. Static analysis in the build. Reviews that check the requirement ID, not just style. Git is evidence: a commit that says “fixed bug” is a hole. Point at the ticket / requirement.
Test and validate as chapters, then hand off. Risk-based: the dose calculator and the laser control get the edge cases (bad image, junk calibration, the thing that is not a tumour). Unit → integration → system → UAT with real clinicians. The software test levels are 700 6112. Intended-use validation and the validation pack are 700 5530. This URL does not become those articles.
510(k) / PMA as a step
Pick the path from intended use and harm, then assemble a file a reviewer can walk. 510(k) is “substantially equivalent” to a predicate. PMA is the high-risk / no-predicate file, often with clinical evidence. Getting the path wrong is a multi-year redo. The how-to is 698 7568. Here it is a step in the process: you do not start a 510(k) on a product with no SRS and no trace.
After clearance you still watch the field, take complaints, and treat a UI tweak that can confuse a dose as a change with a file — not a silent Friday ship. That surveillance how-to is on the device-process and FDA pages, not a second spine here.
FAQ
Is this IEC 62304?
No. 62304 / SaMD vs SiMD / Class A/B/C is medical device software development. This page is generic medical-software SDLC. Do not paste the class table here.
Is this device Phase 0–5?
No. Concept through launch as a device is medical device development process.
Can you use agile?
Yes, if a story is not done until the SRS row and the test exist. Documentation bolted on after month 18 is how reviews fail.