ISO 11070 and FDA Guidance on Guidewire Testing
ISO 11070 is a standard that ensures proper development of a safe and easy to use guidewire. Since the advent of the ISO 11070 standard, there have been various technological advancements that require additional information and clarity for new/modified guidewires, which are called out in a recent FDA Guidance document.
This DDL white paper highlights and compares some of the common test requirements called out in both documents.
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