Testing Strategy & Laboratory Coordination (New Zealand)

Testing Should Generate Evidence the Sponsor Can Defend. NKB Regovanta helps manufacturers identify testing needed to support device safety, performance and risk controls for the New Zealand product. Where third-party testing is required, we can coordinate with established laboratories and review protocols and reports from the perspective of the final regulatory evidence package.

Build Your NZ Testing Strategy

When This Support Is Needed

Existing global test reports do not fully cover the product configurations supplied to New Zealand

Medsafe requests additional pre-clinical safety, electrical, biological, or chemical test data during an inquiry

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

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 New Zealand product lines?

Will the sponsor be able to defend the test data if Medsafe initiates a product safety investigation?

Testing Disciplines We Design & Coordinate

Testing gap assessment against international standards and Medsafe safety expectations

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, IANZ/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)

Final laboratory test report regulatory review prior to technical file integration

Testing Rationale:

Before testing starts, we challenge the tested configuration, worst-case rationale, sample selection, applicable standard, acceptance criteria and linkage to the risk or claim the study is intended to support. We do not simply arrange testing; we connect laboratory output to a defensible regulatory evidence strategy.

Structure Testing That Your NZ Sponsor Can Defend

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

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