Technical Documentation & Safety / Performance Evidence

The Sponsor Must Be Able to Substantiate the Device Behind the WAND Entry. WAND is not a technical-dossier approval process, but a sponsor still has legal responsibilities for the safety of devices supplied in New Zealand. Technical evidence therefore needs to remain available and coherent enough to support the intended purpose, risk controls, performance claims and any Medsafe safety investigation or market action.

Review Your New Zealand Technical Evidence

When This Support Is Needed

Establishing technical file substantiation for devices notified in the Medsafe WAND database

Adapting an overseas EU MDR technical file, Australian TGA dossier, or US FDA 510(k) for New Zealand supply

Responding to Medsafe safety inquiries, product quality investigations, or compliance audits

Verifying end-to-end evidence traceability between risk management files, test reports, and marketed claims

What We Challenge Before Submission

Does the technical documentation support the exact device configuration and intended use supplied in NZ?

Can the sponsor produce complete, current technical files upon Medsafe request without delay?

Are test standards and editions recognized and accepted by international consensus and Medsafe?

Do worst-case product testing rationales scientifically cover all commercial model variants?

Do all risk mitigation controls in the risk file have corresponding, verified test reports?

Technical File Components We Compile & Review

Device description, engineering specifications, models, configurations, and accessories

Intended clinical purpose, indications, contraindications, and marketing claim alignment

Design and manufacturing process flows, critical supplier evaluations, and facility controls

Risk management file and benefit-risk documentation under ISO 14971

Verification and validation testing evidence mapping

Biological evaluation and biocompatibility testing evidence (ISO 10993 series)

Sterilization validation and sterile barrier packaging integrity reports

Packaging transit simulation and real-time / accelerated shelf-life aging evidence

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

Software lifecycle documentation, architecture, and cybersecurity verification (IEC 62304)

Usability and human factors engineering documentation (IEC 62366-1)

Clinical evaluation reports (CER) and clinical safety/efficacy evidence for medical devices

Analytical and clinical performance evaluation evidence for IVDs

Labeling, Instructions for Use (IFU), and promotional brochure consistency review

Post-market surveillance plans and lifecycle documentation update procedures

Evidence Chain Standard:

We review the technical file as one evidence chain: Intended Purpose -> Classification -> Risk -> Verification / Validation -> Clinical or Performance Evidence -> Labelling -> Post-Market. A WAND entry may be simple, but the evidence behind the device should still withstand safety scrutiny.

Substantiate Your Medical Device with Complete Technical Evidence

Our regulatory engineers compile technical documentation, map evidence matrices, and ensure Medsafe audit readiness.

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