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Evidence-Driven Verification
Testing Strategy & Laboratory Coordination
Testing should be designed around the regulatory decision the evidence must support. NKB Regovanta helps define the required studies before execution and coordinates with established laboratories where external testing is needed.
12 Key Regulatory Testing Areas
Biocompatibility and biological evaluation (ISO 10993 series)
Chemical characterization (ISO 10993-18) and toxicological assessment
Sterilization validation (EO, Gamma, Steam) and residual testing (ISO 10993-7)
Packaging validation (ISO 11607), transit simulation (ASTM D4169) and accelerated shelf life
Electrical safety (IEC 60601-1) and Electromagnetic Compatibility (EMC 60601-1-2)
Software verification, validation and lifecycle documentation (IEC 62304)
Cybersecurity verification, threat modeling and vulnerability testing
Usability engineering and human factors validation (IEC 62366-1)
Bench, mechanical, fatigue and functional performance testing
Active-device and specialty device performance verification
IVD analytical performance (sensitivity, specificity, precision, interference)
IVD clinical performance and prospective/retrospective performance studies
What We Challenge Before Testing Starts
1Is the protocol answering the actual GSPR / performance / clinical question?
2Is the selected device configuration scientifically defensible as worst case?
3Are sample quantities, power calculations and lots statistically justified?
4Is the comparator or reference method scientifically appropriate?
5Are endpoints and acceptance criteria justified before execution?
6Are standards current and applicable to the device configuration?
7How will deviations and out-of-specification results be handled and justified?
8Will the final laboratory report be directly usable in the Annex II dossier?
NKB Position
Close the Evidence Gap, Don’t Just Run Tests
We do not simply refer clients to a laboratory. We review the study strategy, protocol logic and final evidence from the perspective of the technical file and Notified Body review, helping avoid studies that “pass” in the lab but do not close the regulatory evidence gap.
Lab Coordination Services
- • Partner accredited test laboratories (GLP/ISO 17025)
- • Protocol drafting & acceptance criteria review
- • Worst-case sample configuration justification
- • Test report integration into Annex II Dossier
Plan Your Study Protocols
Avoid repeat laboratory testing and unexpected Notified Body questions by reviewing protocols upfront.
Review Study ProtocolDesign Rigorous Testing Studies That Satisfy Notified Body Reviewers
Our experts connect design controls, GSPR requirements, and laboratory execution into one seamless evidence package.