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Medical Device Documentation Map
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IFURegulatoryRisk Framework:
1. Intended Use
2. Regulatory Strategy
3. Hazard Analysis
4. Applicable StandardsuFMEAProduct
ReqtsSystem
Hazard
AnalysisPRSdFMEASystem
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What is medical device documentation map?
The medical device documentation map is a tool used to organize and maintain all documentation related to a medical device throughout its lifecycle.
Who is required to file medical device documentation map?
Manufacturers and distributors of medical devices are required to file a medical device documentation map.
How to fill out medical device documentation map?
The medical device documentation map should be filled out by including all relevant documentation such as design specifications, testing results, and labeling information.
What is the purpose of medical device documentation map?
The purpose of the medical device documentation map is to ensure that all necessary documentation is in place to demonstrate the safety and effectiveness of the medical device.
What information must be reported on medical device documentation map?
Information such as design history, risk analysis, quality management system documentation, and labeling information must be reported on the medical device documentation map.
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