n-Vitro Diagnostics Inspection AI

Bring real-time intelligence to every IVD inspection on the line with Vision AI. Built for the operations where one defective test strip, mislabeled lateral flow assay, or mis-aligned analyzer component can trigger a recall, an EU IVDR notified body audit finding, or a missed diagnosis. Whether you're inspecting nitrocellulose membranes, lateral flow cassettes, test strip lamination, microfluidic cartridges, reagent fills, or analyzer mechanical and optical assemblies, Roboflow extends your QC coverage to every device on the line, on the cameras and inspection stations your facility already runs, validatable under FDA 21 CFR Part 820, ISO 13485, and EU IVDR.

Test Strip and Lateral Flow Inspection:

• Detect membrane defects, contamination, and uneven coating on nitrocellulose membranes before assembly
• Verify test line, control line, and dye placement on every strip and lateral flow cassette
• Catch lamination flaws, housing seal issues, and printed graphics errors before final sealing

Analyzer, Cartridge, and Microfluidic Inspection:

• Inspect microfluidic channel geometry, ports, and bonding on diagnostic cartridges
• Verify analyzer mechanical assembly, optical alignment, and cuvette or detector placement
• Catch reagent fill level, color accuracy, and bubble or particulate issues in liquid components

Reagent Packaging, UDI, and Compliance:

• Verify foil seal integrity, blister pack closures, and desiccant placement on every reagent unit
• Read and verify UDI 2D codes, lot numbers, and expiration dates against FDA and EU IVDR requirements
• Maintain a validated audit trail for FDA 21 CFR Part 11 electronic records

Bring intelligence to every device today. Stop defects from becoming recalls, audit findings, or missed diagnoses.

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Frequently asked questions

What is in-vitro diagnostics inspection with Vision AI?

In-vitro diagnostics inspection with Vision AI uses computer vision models to inspect IVD products at every stage of production, from nitrocellulose membrane coating and test strip lamination through lateral flow cassette assembly, microfluidic cartridge bonding, reagent fill, analyzer build, and final sterile packaging. The system extends QC coverage to every unit on the line, catching test line and dye misplacement, membrane defects, housing seal issues, fill level errors, and UDI mismatches. IVD manufacturers use it to cut scrap, protect first-pass yield, and document compliance under FDA Part 820, ISO 13485, and EU IVDR across test strip, lateral flow, cartridge, and analyzer product lines.

Can Vision AI inspect lateral flow assay assembly at production speed?

Yes. Vision AI runs at the speeds modern lateral flow assembly lines operate at, with edge-optimized models that process inspection imagery frame by frame without slowing production. Customers typically deploy fixed cameras at the membrane striping station, after housing assembly, and before final pouching, with Roboflow Inference running on local edge hardware so detection happens at the line, not over a cloud round-trip. The system flags marginal cassettes in real time and surfaces only the ones a quality engineer needs to adjudicate, so throughput stays up and your team focuses where it counts.

Does IVD inspection support EU IVDR and FDA Part 820 acceptance criteria?

Yes, and the EU IVDR transition is exactly where IVD manufacturers feel the most pressure right now. Roboflow models can be trained against your specific EU IVDR (Regulation 2017/746) inspection criteria and FDA 21 CFR Part 820 quality system requirements, including visual and dimensional acceptance criteria documented in your technical file. The system applies the same pass/fail logic your trained inspectors would, against your written specifications, and produces a validated inspection record for every unit. That record supports your IVDR technical documentation, notified body audits, FDA Part 820 design history file, and ISO 13485 quality system audits. Your regulatory and quality teams own the acceptance criteria; Roboflow provides the inspection engine that enforces them at line speed, with audit trails for training data, model versions, and inspection results that pass scrutiny under both IVDR and the directive-era systems still in transition.

Can it integrate with our cleanroom, MES, eQMS, and validation workflow?

Yes. Roboflow Inference exposes a standard API and supports common industrial and life sciences protocols, so Vision AI inspection events flow into your existing MES, eQMS, ERP, and validation workflow. Customers integrate with MasterControl, Veeva Vault QMS, Sparta TrackWise, and custom eQMS platforms through REST, MQTT, OPC UA, and direct database writes, with PLC-level integration to filling, pouching, and analyzer assembly cells where pass/fail decisions need to drive line behavior. Models are designed to be validatable under FDA 21 CFR Part 11, with audit trails for training data, model versions, and inspection results that support IQ/OQ/PQ documentation. Hardware fits ISO 14644 cleanroom environments, and Roboflow's field engineering team helps you select cameras that meet your cleanroom classification and the optical demands of membrane, cassette, microfluidic, and analyzer inspection.

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