BioBench Labs

Independent Biomedical Engineering Services

Find the recalls your inventory missed. Defend the sample sizes your tests use.

BioBench Labs does careful data and statistics work for two kinds of medtech teams. Your first result is free, prices are published, and we show our working.

Start free: missed-recall audit Free sample-size calculator
  • Audit report in 72 hours
  • Prices on the site
  • No patient data needed

Two ways we help

For equipment service teams

Recall & Inventory Cleanup

Independent service organizations (ISOs) and multi-site biomed / HTM teams

When you win a contract, migrate a CMMS or absorb a merger, you inherit a messy inventory. We flag duplicate records, standardize manufacturer and model names, check every device against 24 months of FDA recalls, and hand back your file with the fixes and flags added. Then we can keep watching every client site for you, under your brand.

  • Missed-Recall Audit: Free
  • Quick Cleanup: $750 per site
  • Full Migration: $3 per device
  • Recall Watch: $50 per site per month

Start free How it works

For device makers

VerifyKit: design-verification statistics

Medical-device makers, contract test labs and regulatory consultancies

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.

  • Sample-size calculator: Free
  • DV Stats Pack: $1,500 per test campaign
  • Lab & Consultancy License: $500 per month, billed quarterly

Start free with the calculator How it works

Why teams work with us

We show our working

Every recall match says how strong it is. Every sample size shows its formula, its assumptions and its citations, so your reviewers can check it, not just trust it.

Example: zero-failure success-run
Confidence C   95%
Reliability R  95%
n = ceil( ln(1 − C) / ln(R) )
  = ceil( 58.40 )
  = 59 units, 0 failures

Fast turnaround

72 h

for the missed-recall audit. Statistics sections in 2 business days for pilot labs.

Free first result

A free audit for one site, a free calculator and a free 30-day lab pilot. Your first Quick Cleanup site is paid after delivery.

Transparent pricing

Every price is on the pricing page, with founding offers and payment terms. No "contact us for a quote" walls.

Honest limits

A recall report is a review aid, not a determination. Our statistics are an engineering aid, not regulatory advice. We say so up front.

No patient data

We work with equipment lists and bench-test data only. Do not upload patient information (PHI). Equipment lists only.

How it works

For equipment service teams

Recall & Inventory Cleanup

  1. Send one export

    Export one client site’s asset list from your CMMS (CSV or Excel) and upload it with the request form. No patient data.

  2. Get the audit in 72 hours

    Open recalls from the last 24 months matched to your devices and graded by match strength, plus duplicate and missing-data counts.

  3. Clean up and keep watching

    If it’s useful, we clean the inventory and send a branded monthly recall exposure report for every site.

For device makers

VerifyKit: design-verification statistics

  1. Share your requirements

    Send the requirement list, the risk-file extract and your protocol or report template. A free calculator result is a fine starting point.

  2. Get the rationales

    A sample-size rationale for each requirement, linked to your risk file, with the method and the calculation shown.

  3. Get the analysis sections

    After testing, the statistical analysis section for each report, in your template. One round of revisions; your team approves.

What you'll receive

Before you send anything, look at the real outputs. Our samples were made with the same tools we use for clients, for a fictional client.

  • Recall work: an audit report with every possible recall match graded by strength, your spreadsheet back with standard names and flags added, and a monthly report under your brand.
  • DV statistics: sample-size rationales with the formula and citations shown, and analysis sections in your own template.
  • Every paid job: a written quote you accept before work starts.

See the recall samples See the statistics samples

Sample · Fictional Data* Sample Missed-Recall Audit report for a fictional clinic: summary cards (28 assets reviewed, 16 with potential recall matches, 46 open recall matches, 2 likely duplicate records, 5 models with inconsistent naming, 1 incomplete record) above a table of recall matches, each graded by match strength.

Free Missed-Recall Audit report, sample for a fictional clinic. Download a sample report (PDF, 63 pages, 560 KB, fictional client)

* All samples use fictional data. Client files are confidential: they are never shown publicly or reused in samples.

Pricing

For equipment service teams

Start free

Missed-Recall Audit

Free

Send a CMMS export from one client site. Within 72 hours you get a missed-recall and duplicate-asset report.

Start free

First site: pay after delivery

Quick Cleanup

$750 per site up to 1,000 devices, then $0.50 per device above that

  • First site: pay after delivery.
  • Included free for every site on a full-price annual Recall Watch plan.

A fast fix for one site’s inventory: duplicates flagged, names consistent, recalls checked.

Request Quick Cleanup

Full Migration

$3 per device $1,500 minimum

For a CMMS migration or a new contract: your inventory with standardized names and duplicates flagged, mapped and ready to import into your own system.

Request Full Migration

Founding offer: 10 places

Recall Watch

$50 per site per month billed annually ($600 per site per year)

Founding price: $35 per site per month ($420 per site per year), locked for 2 years
Open to the first 10 service companies, with a minimum of 5 sites.

  • Quick Cleanup included free for every site on a full-price plan (not with the founding price).

A white-label monthly recall exposure report for each client site, sent under your brand.

Request Recall Watch

For device makers

Start free

Sample-size calculator

Free

Success-run, attribute and tolerance-interval sample sizes, each with a copy-paste rationale paragraph and citations.

Open the calculator

Founding offer: 3 projects

DV Stats Pack

$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.

Request DV Stats Pack

Free 30-day pilot

Lab & Consultancy License

$500 per month, billed quarterly ($1,500 per quarter) or $5,400 per year paid annually (save 10%)

  • Starts with a free 30-day pilot (up to 2 sections). No obligation, and you keep everything delivered.

White-label statistics sections for your client reports, up to 4 a month, for contract test labs and regulatory consultancies.

Start the free pilot

Full pricing, what's included and how payment works

Questions

What do I need to send for the free audit?

A spreadsheet export of one client site's equipment from your CMMS: asset ID, manufacturer, model, serial and department are enough. No patient information.

Is the recall report real-time alerting?

No. It is a monthly review of public FDA recall data, which arrives after the manufacturer's letter. It helps you catch what slipped through and show your clients the work.

Do you sign the statistics?

We prepare and explain the statistics, and your team reviews and approves them. Regulatory decisions and submissions stay with you.

How do I pay?

Invoices are in US dollars, payable by US bank transfer (ACH) or international wire. Card payments are available on request and add 3%. See pricing for details.

Where are you based?

We are an independent business based in Jordan that serves clients remotely. Everything runs by email, video call and the request portal.

Start with a free first result

A missed-recall audit for one site, a free calculator result, or a 30-day statistics pilot for your lab. No commitment.

Start free See pricing