Free for MedTech teams

Free tools for diagnostics, SaMD and QMS

Nigah for CT windowing and a classical baseline, plus first-pass helpers for pathway, software class, risk, reader agreement, prevalence-adjusted PPV, assay QC and study size. Educational — not a submission, not medical advice.

Imaging research

A free CT bench for windowing, measurement, and a classical baseline you can audit. Synthetic phantoms only — not a diagnostic device.

Nigah

Read synthetic CT phantoms, open the NXH-EXP-001 sample cohort, and score a classical candidate rule. A DICOM you open stays in the browser.

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.

SaMD IMDRF category

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

IEC 62304 software safety class

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

ISO 14971 risk matrix

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

EU MDR class helper

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

21 CFR Part 11 checklist

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

ISO 13485 gap self-score

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

CAPA priority scorer

Severity × occurrence × detectability for complaint and nonconformance intake.

Change-control classifier

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

SaMD PCCP checklist

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

IEC 62366 use-error severity

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

IRB review-type helper

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

Intended-use claims highlighter

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

ISO 10993 endpoint picker

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

Sterilization modality picker

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

Privacy, copy & studies

De-identification, readability, sample size, agreement, and the small study calculators.

HIPAA Safe Harbor scanner

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

Informed-consent readability

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

Clinical sample-size calculator

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

Diagnostic 2×2 calculator

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

Prevalence-adjusted PPV

Move sensitivity and specificity into a new prevalence and see PPV, NPV and counts per 1,000.

Cohen's kappa

Two readers, one yes/no call. Observed agreement, chance agreement and kappa.

Westgard QC rules

1-2s, 1-3s, 2-2s, R-4s, 4-1s and 10x on a control series.

Block randomization list

A seeded permuted-block allocation you can download. Same seed, same list.

Coefficient of variation

Mean, SD and coefficient of variation from replicate measurements.

LoD estimator

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

Wear-time / data coverage

Usable hours vs prescribed wear for biosensor and RPM studies.

Youden index

Sensitivity plus specificity, minus 1, for comparing a cutoff.

P value calculator

One-sided and two-sided p values from a z, t, or chi-square statistic.

Chi-square calculator

Pearson's chi-square and p value for a 2×2 table.

Fisher exact test

Two-sided exact p value for a small 2×2 table.

Confidence interval

A t interval for a mean, or a Wilson interval for a proportion.

Relative risk

Relative risk, odds ratio, and risk difference from a 2×2 table.

t test calculator

Welch, Student or one-sample t test from summary stats: t, df, p value and 95% CI.

Odds ratio calculator

Odds ratio and 95% CI from a 2×2 table, with a zero-cell correction.

Effect size calculator

Cohen's d and Hedges' g from two groups, or one-sample d, with Cohen's bands.

Number needed to treat

NNT or number needed to harm from treated and control event counts.

Bland-Altman plot

Bias and 95% limits of agreement for two measurement methods.

Vendor BAA vs DPA picker

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

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.

GS1 UDI AI parser

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

FHIR JSON checker

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

Wearable battery-life estimator

Hours of operation from battery mAh and average current draw.

Shelf-life Q10 estimator

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

Frequently asked questions

Are these MedTech tools free?: Yes. Every calculator and helper on this hub is free to use in the browser. There is no paid unlock for the public tools listed here.
Do I need to create an account or log in?: No login is required to run these tools. Sign in is only for product or admin areas, not for the public calculators on this hub.
Who are these tools for?: MedTech manufacturers, diagnostics and SaMD teams, quality and regulatory staff, and clinical researchers who need educational first-pass helpers for pathway, software class, risk, agreement statistics, assay QC, and study size — not a submission and not medical advice.
What categories of tools are on this hub?: Four groups: Imaging research, Regulatory & QMS, Privacy, copy & studies, and Device identity.
How do I contact NexaMedTech about a tool finding?: Use the contact form at /contact. We do not publish a separate email, phone, or mailing address for tool support — the form is the channel for program and regulatory questions.
Do you store the data I enter in these tools?: No. Hub tools run in your browser and do not upload or store the values you type (for example, pasted text or calculator inputs). Clear the page or close the tab if you used sensitive sample data.

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