HOS  ·  Healthcare Operating System

From the swab to the deposit. One operating system.

Pro-Lab is the integrated stack that runs modern lab and practice operations — from collection kits and instrumentation, to LIMS and billing software, to FDA consulting and clinical-trial enablement. Nine services. One vendor. ISO 13485, FDA-cleared, CLIA-certified.

Explore the Stack Talk to Pro-Lab
✓ ISO 13485 manufacturer
✓ FDA-cleared products
✓ CLIA-certified reference lab
✓ 21 CFR Part 11 ready
Layered visualization of the Pro-Lab Healthcare Operating System: clinical lab analyzer, collection kits, and a software dashboard, stacked together
Healthcare OS · Layered Stack
The Stack

One ecosystem. Nine services. Zero handoffs.

Every other vendor sells one piece. Pro-Lab ships the operating system — the full stack of clinical-lab and practice infrastructure, designed to integrate end-to-end so your data, billing, compliance, and supply chain stop fighting each other.

01 / POL

Physicians Office Labs

Turn-key in-office laboratory. Equipment, FDA-cleared assays, LIMS, billing, kits, compliance — one program.

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02 / Software

Pro-LIMS®

Cloud LIMS for clinical labs. Sample-to-result-to-claim, with AI-driven billing and proficiency tracking built in.

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03 / Software

Pro-LIMS Inventory

Lab inventory, lot/expiry, QC, CAPA, audit trail. Barcode/QR scanning. Starter to Institutional.

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04 / Platform

Pro-Amp™ Molecular

High-complexity isothermal amplification panels. Pathogen ID + resistance markers in 30–60 minutes.

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05 / Platform

Microbank® Marketplace

Cryostorage management + B2B strain exchange. The Microbank®-native digital layer.

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06 / Software

Pro-Temp

Audit-grade temperature monitoring. 21 CFR Part 11, CLIA, ISO 13485, cGMP. Bring your own sensors.

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07 / Services

Practice Management

Scheduling, billing, payer credentialing, and revenue-cycle services tuned for diagnostics-heavy practices.

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08 / Services

Clinical Trials

Site enablement, sample logistics, kit fulfillment, central-lab and CLIA-grade analytics for IVD and Rx trials.

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09 / Services

FDA Consulting

510(k) strategy, ISO 13485 QMS, design controls. From a regulatory team that ships its own FDA-cleared products.

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01 Physicians Office Labs

The turn-key in-office lab. Same-visit results.

The full operating model for a profitable, compliant in-office lab: equipment, FDA-cleared assays, Pro-LIMS with integrated billing, collection kits, consumables, compliance documentation, and a CLIA-certified reference lab as backup. Patients can leave with the result. Antibiotics get chosen before the script is called in to the pharmacy.

  • Bundled equipment + assays + LIMS + billing + kits + support
  • Stark in-office ancillary services exception documentation
  • labtest.bio reference-lab backup for overflow and send-outs
  • Subscription / revenue-share / bundled program structures
Visit POL page →
In-Office Modern physician office laboratory with chemistry analyzer, hematology analyzer, and a gloved hand loading a sample
Software Pro-LIMS dashboard on a curved monitor showing throughput, status, and revenue charts
02 Pro-LIMS®

The LIS, billing engine, and proficiency tracker. One system.

Pro-LIMS is the cloud lab information system purpose-built for clinical labs. Sample-to-result-to-claim in one platform: instrument integrations, role-based access, audit trail, and an AI-driven billing module that scrubs claims with payer-specific rules before they ship.

  • Order entry, accessioning, instrument interfaces, results review
  • Integrated billing: CPT, modifier QW, payer edits, denial workflow
  • Proficiency-testing tracking and competency assessments
  • HIPAA-aligned, audit-trail logging, role-based access
Talk to a Pro-LIMS specialist →
03 Pro-LIMS Inventory

Lab inventory, lot/expiry, QC, and CAPA. Audit-ready, day one.

The inventory side of the LIMS stack. Pro-LIMS Inventory tracks every reagent, control, and consumable through its full lifecycle — requested, approved, ordered, received, QC, released, transferred, depleted — with audit-trail logging on every transition. Barcode and QR scanning for check-in/check-out.

$99/mo
Starter tier
14 day
Free trial
∞
Sites · Institutional
  • Full lifecycle: requested → approved → ordered → QC → released → depleted
  • Barcode + QR scanning, label printing, bulk CSV import/export
  • QC workflows, CAPA management, equipment tracking
  • Starter, Professional, Business, and Institutional tiers
Visit Pro-LIMS Inventory →
Inventory Gloved hand scanning a barcode on a labeled clinical reagent bottle with a smartphone, lab shelves of reagents in the background
Molecular Compact molecular diagnostic instrument with a clear PCR cartridge being inserted, gloved hand visible
04 Pro-Amp™ Molecular Platform

Pathogen ID and resistance markers during the visit.

Pro-Amp™ is our high-complexity isothermal amplification platform. Multiplex panels for respiratory, UTI, GI, STI, and vaginitis return pathogen identification plus key resistance markers in 30–60 minutes — targeted antibiotics chosen before the script is called in to the pharmacy.

  • Isothermal amplification — no thermocycling, no big footprint
  • Multiplex panels: respiratory, UTI, GI, STI, vaginitis
  • Genotypic resistance markers (e.g. mecA, ESBL, vanA/B)
  • Designed for high-complexity CLIA labs and physician offices alike
Read the Pro-Amp™ brief →
05 Microbank® Marketplace

Cryostorage management. Plus a B2B strain exchange.

The only Microbank®-native digital layer — a mobile + web app that turns paper-and-tribal-knowledge cryostorage into a searchable, scannable inventory and connects labs to a peer-to-peer strain marketplace. Stop hoarding cultures. Stop dumping them. Start exchanging them.

  • Find any vial in 10 seconds — barcode, QR, or smart search
  • Multi-user permissions, audit logging, freeze/thaw history
  • Peer-to-peer strain exchange — turn your inventory into a tradeable asset
  • iOS, Android, and web. Built on the Microbank® cryostorage system.
Visit Microbank Marketplace →
Biobanking A cryostorage box of color-coded vials with vapor from a freshly opened freezer
Cold Chain Wireless temperature sensor inside a lab-grade refrigerator with cold vapor; tablet in the foreground showing a teal temperature trend line
06 Pro-Temp

Audit-grade temperature monitoring. Without the enterprise quote.

Real-time temperature monitoring with audit trail and calibration tracking, designed to support 21 CFR Part 11, CLIA, ISO 13485, and cGMP audits. Bring your own sensors — anything that can POST JSON connects in a day. Transparent per-device pricing in a category that's normally quote-only.

  • Real-time alerts: SMS, email, webhook, on-call escalation
  • Calibration tracking, electronic signatures, audit trail export
  • Bring-your-own-sensor: any device that can POST JSON
  • Per-device, published pricing — from $69.99/device/month
Visit Pro-Temp →
07 Practice Management

The revenue cycle for a diagnostics-heavy practice. End to end.

Most practice-management vendors pretend the lab doesn't exist. Pro-Lab's practice management services are built for the opposite case — practices where in-office testing is a meaningful slice of revenue. Scheduling, eligibility checking, charge capture, claim scrubbing, denial workflow, and payer credentialing tuned for the CLFS-and-PFS reality.

  • Scheduling and patient intake integrated with lab order flow
  • Charge capture across CPT (PFS) and CLFS test billing
  • Payer credentialing for the lab's billing identifier
  • Denial management, appeals, and payer-rule maintenance
Talk to us about practice ops →
Practice Ops Modern medical practice front desk with a monitor showing a teal scheduling calendar, paper stack, and phone — clean uncluttered reception area
Trial Logistics Gloved hand sealing a clinical-trial sample shipping kit containing color-capped sample tubes, an ice pack, and a wireless temperature data logger
08 Clinical Trials

Trial enablement for IVD and Rx programs. From sample to dataset.

We support sponsors and CROs with the parts of a trial most likely to slip: site-level sample logistics, kit fulfillment, central-lab analytics under our CLIA certificate, and audit-grade documentation. Our regulatory team has navigated the same submissions you'll face — we ship FDA-cleared products of our own.

  • Investigator-site kit fulfillment, returns logistics, chain-of-custody
  • Central-lab analytics under our CLIA-certified reference lab
  • Pro-LIMS deployment for site-level data capture and audit trail
  • Documentation packages tuned to FDA submission requirements
Talk to clinical operations →
09 FDA Consulting

From 510(k) strategy to ISO 13485 QMS. By people who've shipped it.

Our regulatory team didn't read about FDA submissions in a textbook — we've filed our own. Pro-Lab is an ISO 13485:2016 manufacturer with FDA-cleared products in market. We help device and IVD startups get to clearance, and help mature manufacturers fix what their internal QMS team couldn't.

  • 510(k) submission strategy and authoring, predicate analysis
  • ISO 13485 QMS implementation and gap remediation
  • Design controls (21 CFR 820.30), CAPA, complaint handling
  • Pre-submission strategy, FDA Q-Sub support
Talk to a regulatory consultant →
Regulatory Executive desk with leather portfolio, document stack with green checkmark, and a tablet displaying a teal compliance flow diagram
Why HOS

A stack, not a marketplace.

Most healthcare vendors sell one piece and shrug at the integration. Pro-Lab built every layer to talk to the next one. Your data, your billing, your compliance posture, and your supply chain stop fighting each other when one vendor owns the whole stack.

Integrated by default

One data model from order entry to claim submission. No HL7 duct tape between vendors who don't return your calls.

Compliance-first

ISO 13485 manufacturer. FDA-cleared products. CLIA reference lab. 21 CFR Part 11 software. Receipts, not promises.

One number to call

Instrument issue, billing question, audit prep, software bug. Same line, same team, same accountability.

Full stack, no vendor sprawl

Equipment, software, kits, consumables, services. Six contracts collapse into one program.

✓
ISO 13485:2016
Medical Device QMS
✓
FDA Registered
IVD Manufacturer
✓
CLIA Certified
High-Complexity Reference Lab
✓
21 CFR Part 11
Electronic Records / Signatures
✓
CMS / Medicare
CLFS Billing Compliant
Talk to Pro-Lab

One operating system. One conversation to start.

Tell us where you are — standing up a POL, picking a LIMS, planning an FDA submission, or trying to bring a clinical trial in-house. We'll come back with the slice of HOS that fits.

Talk to Pro-Lab support@pro-lab.us