For device makers
Every design-verification test needs a sample size you can justify and an analysis you can defend. We write the rationale for each requirement, analyse your bench data, and draft the statistics sections in your template. Your team reviews and approves the work.
Built for Medical-device makers, contract test labs and regulatory consultancies.
Anyone can get n = 59 from a formula. What reviewers push on is everything around it: why that confidence and reliability for this risk, whether the units represent the spec range, what happens if the data are not normal, how lots were pooled, and what you do with an outlier.
We write those arguments down for each requirement, in your template, so your engineers can review and own them.
Starting niche: ISO 11607 package tests (ASTM F88 seal strength, F1140/F2054 burst, F1929 dye penetration, F2096 bubble leak). Bond, tensile and ISO 80369-7 connector tests by agreement.
Send the requirement list, the risk-file extract and your protocol or report template. A free calculator result is a fine starting point.
A sample-size rationale for each requirement, linked to your risk file, with the method and the calculation shown.
After testing, the statistical analysis section for each report, in your template. One round of revisions; your team approves.
Free
No sign-up
Success-run, attribute and tolerance-interval sample sizes, each with a copy-paste rationale paragraph and citations.
$1,500 per test campaign
Founding price: $1,200 for the first 3 projects
In exchange for a short testimonial, which will say you received a founding discount. You can say no.
A fixed-price statistics package for one design-verification test campaign, for teams preparing a 510(k) or De Novo.
Payment: 50% to start, 50% on delivery.
$500 per month, billed quarterly ($1,500 per quarter) or $5,400 per year paid annually (save 10%)
White-label statistics sections for your client reports, up to 4 a month, for contract test labs and regulatory consultancies.
A real result from the free calculator, run on example inputs. Each rationale we write starts from a calculation like this one, then adds the link to your risk file and the argument for why the test units represent production, in your template.
Free calculator result. 95% reliability with 95% confidence gives n = 59, with the formula, a rationale paragraph and its citations. Sample result for example inputs; the bracketed parts are yours to fill in.
It appears on screen as soon as you send the form, for example BBL-2026-0042. With it and your email you can follow progress on the status page. No account or password.
We reply within 2 business days. We look at your request and any file you sent, and ask if anything is unclear.
Paid work starts only after you accept a written quote with the scope, price, timeline and payment terms. Quotes are valid for 30 days, and you can simply decline.
Reports and files are downloaded from the status page with your reference number and email.
| Step | Who | What |
|---|---|---|
| 1 | Lab | Signs your standard mutual NDA. Sends your report template and one or two past reports (de-identified) as style references. |
| 2 | Lab | For each pilot report, sends the raw export (Bluehill, MTS, Excel or CSV), the client's target (for example 95/99) and the spec limits. Client names can be removed. |
| 3 | BioBench Labs | Returns the statistics section as an editable Word file plus a calculation record within 2 business days. |
| 4 | Lab | Your engineer reviews, edits as needed and signs the report as usual. The lab stays the author of record. |
30 days from kickoff, no obligation, and you keep everything delivered. Email and video calls only. Data are used only to produce your sections and deleted within 90 days after the pilot ends, or sooner if you ask.
Disclaimer. VerifyKit statistics are an engineering aid, not regulatory advice. Regulatory decisions and submissions remain yours, and no one can guarantee FDA acceptance.
One design-verification test plan for one device, for example the ISO 11607 package tests before a 510(k). If you are unsure, describe it in your request and we will confirm the scope in the quote.
To start: the requirement list, the risk-file extract with your confidence and reliability levels, and your protocol or report template. After testing: the raw data export (Bluehill, MTS, Excel or CSV) and the spec limits. Client and product names can be removed.
No. We work from bench-test data and documents only. Please don't send anything that identifies a patient.
Your team. We draft the rationales and analysis sections and explain them; your engineers review, approve and stay responsible for the submission.
Yes. Every calculator result shows its formula and citations, and the self-test page reruns every reference case in your own browser, so your reviewers can check the numbers rather than take them on trust.
A short written testimonial after delivery, which will say you received a founding discount. You can say no if you are not satisfied.
No one can. We cover the points reviewers usually probe and write them down clearly, but regulatory decisions remain yours.
A missed-recall audit for one site, a free calculator result, or a 30-day statistics pilot for your lab. No commitment.