Free for MedTech teams

Free tools for diagnostics, SaMD and QMS

First-pass helpers for pathway, software class, risk, de-identification and study size. Educational — not a submission, not medical advice.

Regulatory & QMS

Educational helpers for pathway, SaMD, software safety class and risk scoring — not a substitute for counsel.

FDA pathway picker

510(k), De Novo, PMA or 510(k)-exempt — a structured first pass from class, predicates and novelty.

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SaMD IMDRF category

Map significance of the information × healthcare situation to IMDRF SaMD categories I–IV.

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IEC 62304 software safety class

Walk harm scenarios to Class A, B or C for medical device software.

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ISO 14971 risk matrix

Score severity × probability, see RPN bands, and keep a short hazard log in the browser.

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EU MDR class helper

A simplified Rule 1–22 walk to Class I, IIa, IIb or III — confirm against Annex VIII.

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21 CFR Part 11 checklist

Electronic records and signatures: unique IDs, audit trail, operational checks, copies.

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ISO 13485 gap self-score

Rate key QMS clauses (document control, CAPA, design, suppliers) for a first gap picture.

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CAPA priority scorer

Severity × occurrence × detectability for complaint and nonconformance intake.

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Change-control classifier

Is this a design, process, labeling, or software change — and does it look reportable?

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SaMD PCCP checklist

Predetermined change control plan prompts for AI/ML intended updates.

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IEC 62366 use-error severity

Score a use error’s harm potential for the human-factors file.

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IRB review-type helper

Exempt vs expedited vs full board — a first pass from risk and population.

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Intended-use claims highlighter

Flag diagnose / treat / prevent / screen language that often expands the intended use.

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ISO 10993 endpoint picker

Nature of body contact × duration → typical biological evaluation endpoints.

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Sterilization modality picker

EtO, steam, gamma, e-beam or H2O2 — constraints from heat, moisture and materials.

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Privacy, copy & studies

De-identification checks, patient-facing readability, and a first-pass sample size calculator.

HIPAA Safe Harbor scanner

Paste text and flag likely matches to the 18 HIPAA identifiers before a dataset leaves the building.

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Informed-consent readability

Flesch–Kincaid grade and reading-ease for consent forms, IFUs and patient apps.

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Clinical sample-size calculator

Two-arm mean or proportion studies — n per arm from alpha, power and effect size.

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Diagnostic 2×2 calculator

Sensitivity, specificity, PPV, NPV, likelihood ratios from TP/FP/FN/TN.

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Assay CV% / precision

Mean, SD and coefficient of variation from replicate measurements.

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LoD estimator

Limit of detection from blank mean and SD (mean + 1.645×SD, first-pass).

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Wear-time / data coverage

Usable hours vs prescribed wear for biosensor and RPM studies.

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Vendor BAA vs DPA picker

HIPAA BAA, GDPR DPA, or both — from PHI, EEA personal data and role.

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Device identity

Check digits used in UDI / GS1 barcodes.

UDI / GTIN check digit

Validate or compute GS1 check digits for GTIN-8, GTIN-12, GTIN-13 and GTIN-14.

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GS1 UDI AI parser

Parse (01) GTIN, (17) expiry, (10) lot, (21) serial from a concatenated AI string.

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FHIR JSON checker

Confirm a payload is JSON with a FHIR resourceType and id — not a full validator.

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Wearable battery-life estimator

Hours of operation from battery mAh and average current draw.

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Shelf-life Q10 estimator

Arrhenius-style Q10 acceleration for a first-pass expiry hypothesis.

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