Testing Strategy & Laboratory Coordination (SFDA)

Testing Should Be Designed to Close a Regulatory Evidence Gap. NKB Regovanta helps manufacturers determine which tests are required to support the SFDA pathway and how those studies should be designed so the resulting evidence is usable in the technical file. Where external testing is required, we can coordinate with established laboratories and review study protocols and reports from the perspective of the final MDMA dossier.

Build Your Saudi Testing Strategy

When This Support Is Needed

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

SFDA has issued a deficiency notice requesting additional physical, electrical, biological, or chemical testing data

A complex device family or multi-component system requires scientifically defended worst-case sample selection

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

A change in raw materials, manufacturing process, software, or sterilization creates new testing requirements

What We Challenge Before Submission

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

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 Saudi product lines?

Will SFDA evaluators be able to trace test results directly to the claims made in the Arabic/English IFU?

Testing Disciplines We Design & Coordinate

Testing gap assessment against SFDA recognized standards and international consensus benchmarks

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

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 SFDA-recognized, ILAC-accredited, 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 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)

Final laboratory test report regulatory review prior to MDMA technical file integration

Protocol Design Rule:

At protocol level, we challenge the tested configuration, worst-case rationale, sample selection, applicable standard, acceptance criteria and whether the study actually answers the safety/performance question it is intended to support.

Structure Pre-Clinical Testing for SFDA MDMA Approval

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

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