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NATA & ISO 17025 Lab Coordination
Testing Strategy & Laboratory Coordination
Testing should be designed around the regulatory question it needs to answer. NKB Regovanta defines the testing strategy from classification, risks, Essential Principles, device claims and conformity evidence, then coordinates with established laboratories where external testing is required.
When This Support Is Needed
New medical device or IVD requiring verification and validation evidence for TGA submission
Predicate or overseas evidence does not fully cover the Australian marketed configuration or indications
TGA application audit identifies a specific testing or pre-clinical data gap
New material, supplier, sterilisation process, software version, packaging system or manufacturing site
Performance claims require additional analytical, bench, usability or clinical substantiation
What We Challenge Before Submission
Worst-case configuration chosen for convenience rather than clinical/safety risk
Protocol acceptance criteria that are not technically or clinically justified
Testing to a standard version that does not fully address the claimed use
Samples that do not represent the final production-equivalent finished device
Final laboratory reports that cannot be cleanly mapped into the Essential Principles checklist
IVD analytical studies disconnected from the claimed specimen type or intended population
Testing Areas We Support & Coordinate
Biocompatibility and biological evaluation (ISO 10993 series)
Chemical characterisation and toxicological risk assessment
Sterilisation validation (EO, Gamma, E-beam, Steam, VHP)
Packaging validation and transportation transit testing (ASTM D4169, ISO 11607)
Shelf-life and accelerated / real-time ageing studies
Electrical safety and EMC testing (IEC 60601-1, IEC 60601-1-2)
Bench and functional performance verification
Mechanical durability, fatigue and tensile testing
Software verification and validation (IEC 62304)
Cybersecurity penetration testing and vulnerability analysis
Human factors and usability engineering validation (IEC 62366-1)
IVD analytical performance studies (sensitivity, specificity, LoD, precision)
IVD clinical performance studies and comparator benchmarking
Device-specific verification and validation protocols
Protocol and final-report regulatory review before dossier inclusion
Laboratory coordination with NATA and ISO 17025 accredited facilities
Senior Regulatory Question:
Will the final test report answer the regulatory question TGA is likely to ask — or merely show that a laboratory test was completed?
Execute Pre-Clinical Testing with Clear TGA Regulatory Alignment
Our team designs study protocols, justifies sample sizes, and oversees testing at accredited laboratories.