Testing Strategy & Laboratory Coordination (UAE)

Testing Should Be Designed Around the Regulatory Question. NKB Regovanta helps manufacturers determine what testing is required to support the UAE registration evidence package and whether existing global test reports can be leveraged. Where new testing is needed, we can coordinate with established laboratories and review protocols and reports from a regulatory perspective.

Build Your UAE Testing Strategy

When This Support Is Needed

Existing global test reports do not fully cover the specific product configurations intended for the UAE

MOHAP or technical evaluators request additional pre-clinical safety, electrical, biological, or chemical test data

A complex product family or modular system requires a scientifically justified worst-case testing model

IVD analytical or clinical performance evaluation studies are required to substantiate diagnostic claims

A raw material, manufacturing process, software version, or sterilization method change requires new test evidence

What We Challenge Before Submission

Does the test protocol evaluate the actual finished commercial device or a scientifically justified worst case?

Are test acceptance criteria directly tied to design inputs, risk controls, and clinical safety thresholds?

Does the lab report clearly document exact model numbers, batch/lot identifiers, and software build versions?

Can the testing data bridge minor engineering variations between international and UAE product lines?

Will MOHAP evaluators be able to trace test results directly to the claims made in the product brochure and IFU?

Testing Disciplines We Design & Coordinate

Testing gap assessment against MOHAP recognized standards and international consensus benchmarks

Applicable standard and test method determination (ISO, IEC, ASTM, CLSI, Pharmacopoeia)

Worst-case device and configuration rationale documentation

Sample size, batch selection, and statistical justification protocols

Pre-test protocol review, acceptance criteria validation, and test article quarantine governance

Coordination with accredited, ILAC-recognized, and GLP-compliant testing laboratories

Biocompatibility and biological evaluation studies (ISO 10993 series)

Chemical characterization and toxicological risk assessment (ISO 10993-17 / ISO 10993-18)

Sterilization validation, bioburden testing, and sterile barrier packaging integrity testing

Packaging transit simulation (ASTM D4169 / ISTA) and real-time/accelerated shelf-life aging studies

Electrical safety and Electromagnetic Compatibility (EMC) testing (IEC 60601 series)

Bench, mechanical, durability, and functional performance testing

Software verification, validation, and automated test execution review (IEC 62304)

Cybersecurity vulnerability assessment and penetration testing evidence

Usability and human factors testing (IEC 62366-1)

MOHAP physical sample and Certificate of Analysis (CoA) readiness where requested

Final laboratory test report regulatory review prior to MOHAP dossier integration

Regulatory Testing Rationale:

At protocol level, we challenge the worst-case device, sample selection, applicable standard, test method, acceptance criteria, deviations and whether the resulting report actually supports the intended use and regulatory claim. We do not simply refer the manufacturer to a laboratory.

Structure Pre-Clinical Testing for UAE MOHAP Approval

Our testing strategists define study protocols, justify worst-case testing rationale, and manage accredited laboratories.

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