Health and medical software — regulatory checks

Rules for software that touches patient data or medical devices: FDA electronic submissions, US Core and USCDI, CMS interoperability APIs, IEC 62304 software lists and HIPAA disclosure accounting.

8 tools

Subscribe to this shelf. One annual key for the 4 linters on this shelf: the workspace sweep and the dated report in each, plus rule updates. Linters added to this shelf later are included. Subscribe to this shelf — $79/yr
For teams. One team key opens every ReadyStack linter for five seats and CI. Team key — $149 once

SOUP List Lint (IEC 62304)

VS Code extension

Reads your SOUP register the way an auditor does: 16 rules over clauses 8.1.2, 5.3.3, 5.3.4, 4.3 and 7.1.3.

Arduino Sensor Code for Food-Safety Temperature Alarms (FDA 41°F / UK 8°C)

The same 46°F walk-in fails the FDA 41°F limit and passes England's 8°C. 6 compiled Uno sketches that latch the alarm until someone resets it.

Arduino Code Temperature Sensor: Food-Safety Fridge, Hot-Hold and Cooling Alarms (FDA 41°F/135°F · UK 8°C/63°C)

6 compile-tested Arduino Uno sketches, no libraries: a latched alarm when a fridge passes 41°F (FDA Food Code) or 8°C (UK), and a cooling clock that fails a batch not at…

SPL Registration Lint - FDA Establishment XML

VS Code extension

Finds the lines the FDA gateway rejects in an SPL establishment registration, and how many days are left in the October 1 - December 31 window.

MDR Legacy Sunset Clock 2026

Browser extension · Chrome, Edge, Firefox

Which Regulation (EU) 2023/607 date your legacy device actually falls under, and how many days are left.

US Core Profile Gap Check (USCDI v3)

VS Code extension

Finds the FHIR R4 resources still pinned to US Core 3.1.1 or 5.0.1, and the USCDI v3 Patient elements they never carried.

HIPAA Disclosure Accounting Clock (2026)

Browser extension · Chrome, Edge, Firefox

Type the date the request landed. Get the 60-day deadline, the one 30-day extension date, the six-year lookback start, whether this one is free or fee-eligible, and what…

CMS-0057 API Gate

VS Code extension

14 rules read a FHIR CapabilityStatement against CMS-0057-F. A 2021 payer statement returned 6 blocking gaps - three of the four APIs missing - and 107 days left to 1…

Questions

Do my files leave my computer?

No. The extensions and command-line checks run on your machine and your files are not uploaded. The browser calculators run in the page.

What does it cost?

Every tool is free for the file or case in front of you. The paid part is a one-time licence key; each tool page shows its price and what the key adds. A team key ($149 once) opens every ReadyStack linter for five seats and CI.

More collections

US payroll, tax and filing deadlines — 2026 checksUK tax, payroll and HMRC rules — 2026/27 checksEU rules with a 2026 date — deadline and fine checksE-invoicing rules — format and deadline checksPrivacy and data protection — rule checksAccessibility — WCAG and EAA checksSecurity and supply chain — linters for the rules that bind softwareDeveloper deadlines — deprecations, removed APIs and build breaksSelling online — pricing, fee, email and consumer-law rulesAI rules and agent configuration — lintersSubmission gates — pass the store or registry review the first timeExam flashcards — licensing and certificationTemplates and design assetsDeutschland 2026 – Fristen, Lohn, Steuer und Pflichten All tools