Testing Strategy & Laboratory Coordination

We design the testing plan backward from the FDA decision the evidence must support — challenging configuration, worst-case rationale, standards, acceptance criteria and whether the resulting data will actually answer the regulatory question.

Build Your FDA Testing Strategy

What This Service Is

Testing should not be treated as an isolated laboratory activity. The protocol, sample configuration and acceptance criteria must be capable of supporting the regulatory claims and device comparison presented in the final submission.

When It Is Needed

Before initiating verification and validation testing for a 510(k), De Novo or PMA program

When predicate differences create specific performance questions

When multiple device configurations exist and worst-case selection must be justified

When prior testing may not fully align with current FDA expectations or intended claims

When an external laboratory needs a regulatory testing brief or protocol review

What We Challenge Before Testing

What regulatory question must the study answer?

Which device configuration is the appropriate worst case?

Are sample size and sample selection scientifically justified?

Are the comparator, endpoints and acceptance criteria appropriate?

Does the selected standard address the actual device characteristic under review?

Will the final report be usable within the FDA submission without major evidence gaps?

Testing Areas We Support

Bench and functional performance

Biocompatibility and chemical characterization (ISO 10993)

Sterilization validation (EO, Gamma, Steam, etc.)

Packaging, transportation and shelf life (ASTM / ISO 11607)

Electrical safety and EMC (IEC 60601 series)

Software verification and validation (IEC 62304)

Cybersecurity premarket documentation

Human factors and usability engineering (IEC 62366 / FDA guidance)

Mechanical, flow and pressure testing where applicable

IVD analytical and clinical performance

Other device-specific verification and validation

Laboratory Coordination

Where external laboratories are required, we can help define the regulatory testing scope, review protocols before execution, assess worst-case rationale and review final reports from the perspective of how the evidence will be used in the FDA dossier.

Our Difference

Regulatory Intent Guides the Test Design

We do not simply ask which test is required. We ask what regulatory question the test must answer and whether the chosen study design can support the submission decision.

Avoid Common Testing Pitfalls

Unjustified sample size or test configuration
Testing wrong worst-case variant
Outdated standard version cited
Missing clinical/regulatory acceptance criteria

Optimize Testing Budget

Ensure every test dollar produces evidence that FDA reviewers will accept without pushback.

Build Testing Strategy

Need an FDA-Defensible Testing Strategy?

Our technical experts review test plans and laboratory protocols before expensive testing begins.

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