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Summary Technical Documentation (STEP):
Harmonizing a Predictable Regulatory Submission
By the HarmonizationbyDoing Working Group 4Introduction
Practical experience harmonizing global submissions
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What is summary technical documentation sted?
Summary Technical Documentation (STED) is a structured format for preparing a premarket submission that includes information about the design, manufacture, and performance of a medical device.
Who is required to file summary technical documentation sted?
Manufacturers of medical devices are required to file summary technical documentation sted.
How to fill out summary technical documentation sted?
Summary technical documentation sted can be filled out by providing detailed information on the design, manufacture, and performance of the medical device in a structured format.
What is the purpose of summary technical documentation sted?
The purpose of summary technical documentation sted is to provide regulators with comprehensive information about the design, manufacture, and performance of a medical device.
What information must be reported on summary technical documentation sted?
Information about the design, manufacture, and performance of the medical device must be reported on summary technical documentation sted.
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