IVD Precision Manufacturing

Accurate DiagnosticOrchestration

The gold standard for IVD kit and reagent production. Our EFM platform synchronizes precision dispensing, batch-to-vial genealogy, and IVDR compliance for global diagnostic leaders.

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100%

IVDR Compliance

0.01ml

Dispense Accuracy

Real

Time LIMS Sync

REAGENT_BATCH_VERIFIED

Monitoring Filling Line F2

Purity: 99.98%

IVD & Diagnostics Solutions

Ensure the accuracy of every test result with a manufacturing core designed specifically for high-precision diagnostic kits and reagents.

Precision Dispensing Sync

Native integration with automated filling and capping lines to monitor dispense volumes and torque values in real-time.

Kit-to-Batch Genealogy

Maintain perfect traceability between individual diagnostic kits and the specific reagent bulk batches they contain.

EU IVDR & FDA Compliance

Built-in technical documentation structures and audit trails required for global In Vitro Diagnostic regulations.

Electronic Batch Records

Replace physical paperwork with dynamic eBRs that capture every critical process parameter and lab verification.

Bi-Directional LIMS Sync

Seamless flow of quality data between the shop floor and the laboratory for instant release decisions.

Cold-Chain Integrity

Real-time monitoring of temperature-sensitive raw materials and finished goods through the entire production cycle.

Accuracy Starts on the Floor

Our platform eliminates human error in diagnostic manufacturing, ensuring that the data driving medical decisions is 100% reliable.

Zero Measurement Errors

Automate dispense validation to prevent incorrectly formulated reagents from reaching the kit assembly line.

Instant DHR/BR Review

Release batches faster by automating the review of compliant production records.

Waste Reduction

Identify and stop filling errors in seconds, saving expensive biological raw materials.

Diagnostics Impact Benchmarks

Dispense Accuracy99.9%

Batch Release Speedup45%

Audit Pass Rate100%

Reagent Waste Reduction25%

Diagnostics Industry Insights

Navigating the Future of IVD Manufacturing

Q. How does the platform handle IVDR technical documentation?

We provide structured data fields that automatically populate GSPR (General Safety and Performance Requirements) records based on shop floor quality data.

Q. Can we track reagent expiration dates during assembly?

Yes. Our MES enforces material validation, preventing any expired or unreleased reagents from being used in kit assembly.

Q. Is there support for complex kit multi-packs?

Absolutely. The system manages nested hierarchies, linking every individual vial and component serial number to the final parent kit SKU.

Enable Certainty.

Join the global diagnostics leaders building the future of IVD integrity on Hackaback.

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