International laboratory and IVD support
AssayIQ works remotely with laboratories and diagnostics teams beyond the United States on technical studies, quality systems, documentation, and operational decisions. Every engagement starts with the country, product or test, intended use, and the standards that apply.
Four ways to work together
Choose a focused deliverable or combine services into a phased program. Your authorized scientific, clinical, and regulatory leaders retain the final decision.
A diagnostic team needs defensible performance data before a product decision or submission.
Study plans and analysis for precision, measuring interval, method comparison, interference, and other agreed analytical claims. We organize raw data, traceability, acceptance criteria, limitations, and the final technical report.
An evidence package for the manufacturer's scientific and regulatory reviewers.An established or expanding lab needs a stronger, more consistent quality system.
Gap assessment, document control, SOPs, internal audit planning, nonconformity and corrective-action tracking, quality indicators, and management review support against the client's applicable requirements.
A prioritized action register and organized evidence for the chosen accreditation pathway.A laboratory or diagnostics company wants to serve a new country but the evidence and decision owners are scattered.
Inventory the intended use, test claims, existing studies, quality records, labeling inputs, and jurisdiction-specific questions. Coordinate a review with qualified local regulatory specialists when the project requires one.
A documented evidence gap map, work plan, and owner list before a filing decision.An instrument, method, or information system is ready to install but the acceptance evidence is incomplete.
Implementation requirements, vendor questions, installation and functional checklists, data integrity review, user training records, go-live issue logs, mock audit preparation, and follow-up measures.
A review-ready handoff that shows what was tested, what remains open, and who approves use.How international projects begin
Requirements are different for a clinical laboratory, an IVD manufacturer, and a software product. A short discovery review establishes which system applies before we quote a study or build a document set.
Discuss a global projectAssayIQ can deliver remote analytical, quality, and operational work across borders, subject to a project-specific review of data handling and local requirements. Regulatory classification, legal representation, authorized representative duties, submissions, notified-body interaction, and certification require the client's authorized team or an appropriately qualified local specialist. Neither clearance nor accreditation is guaranteed.
Independent learning
These external resources are published by the named public agencies. They are provided for background and are not AssayIQ training or an endorsement.
Recorded training on how FDA classifies IVD products and connects classification to the premarket pathway.
Open resource U.S. FDAOfficial multimedia modules covering medical device and IVD regulation across the product lifecycle.
Open resource WHOTraining materials for building practical quality management systems in laboratories.
Open resource