Back to Canada Overview
Lab Coordination & Protocol Review
Testing Strategy & Laboratory Coordination
Testing should be designed around the regulatory question the evidence must answer. NKB Regovanta helps manufacturers define the evidence strategy before studies are initiated and can coordinate testing with established laboratories where external testing is required.
Testing Areas We Can Support
Bench and functional performance testing
Biocompatibility and chemical characterization (ISO 10993)
Sterilization validation (EO, Gamma, Steam, VHP)
Packaging and transportation validation (ASTM D4169, ISO 11607)
Shelf-life and accelerated/real-time ageing studies
Electrical safety and EMC (IEC 60601-1, IEC 60601-1-2)
Software verification and validation (IEC 62304)
Cybersecurity testing and supporting vulnerability documentation
Human factors and usability engineering (IEC 62366-1)
Mechanical and durability testing
IVD analytical performance studies
IVD clinical performance studies
Other product-specific verification and validation
How NKB Approaches Testing
1
Define what regulatory question the test must answer.2
Confirm applicable recognized or relevant standards.3
Challenge sample selection and device configuration.4
Identify appropriate worst-case rationale where relevant.5
Review comparator/reference method selection.6
Review acceptance criteria before study execution.7
Review protocols for regulatory adequacy.8
Review deviations and their impact on interpretability.9
Review reports before dossier integration.10
Trace the resulting evidence back to the licence application and claimed performance.Our Difference:
We do not simply refer the client to a laboratory. We sit between the manufacturer, laboratory and Health Canada dossier so the generated evidence is fit for regulatory review and does not have to be recreated later.
Coordinate Your Pre-Clinical Testing with Expert Regulatory Oversight
Our engineers define acceptance criteria, justify sample sizes and worst-case test articles, and manage accredited laboratories.