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Testing strategy that connects design intent to defensible evidence.

Define methods, fixtures, samples, acceptance criteria and traceability that answer the actual engineering question.

Catheter Testing, Verification & Validation

Ask one clear question per method

A test method should state the performance attribute, loading condition, measurement system and decision rule. Combining unrelated outcomes can obscure failure mechanisms.

Qualify fixtures and measurements

Fixture compliance, alignment, grip damage, sampling rate and operator technique can dominate results. Method development must separate product behavior from test-system artifacts.

Plan traceability early

Design inputs, risk controls, methods, acceptance criteria and reports should form a clear evidence chain. Early planning prevents verification from becoming a documentation scramble.

A useful next step

Share a non-confidential summary of the application, development stage, current architecture and most important uncertainty. From there, the appropriate review, analysis or training scope can be identified.

This content is educational and is not medical advice or a substitute for applicable quality and regulatory requirements.