AstraPurpose

AstraPurpose is a tool to create the intended purpose statement according to MDR or IVDR. Use it, step-by-step and create the intended purpose statement of your medical device. Use it throughout your Technical Documentation, thus avoiding incorrect, incomplete or different statements. Why is this so important? Because the intended purpose is the foundation of your Technical Documentation. It should be precise, correct, complete and everywhere identical. All claims that are part of your statement need to be verified in your clinical performance or performance evaluation documents.

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