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Acceptance Criteria & Boundary Condition Development

Engineering Services

Acceptance criteria and boundary condition development

Acceptance criteria and boundary condition development

Defining robust clinically relevant acceptance criteria and boundary conditions can be a significant hurdle in the medical device development process. The clinical environment can be complex and highly variable. We have developed the acceptance criteria and clinical conditions for hundreds of devices in a wide range of clinical environments. Our efforts have helped produce medical devices that successfully stand up to their intended use and the requirements for regulatory approval.