SYSTEM FOR COLLECTING AND MANAGING RISK MANAGEMENT FILE AND SAFETY ASSURANCE CASE DATA
First Claim
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1. An apparatus for collecting and processing risk management and safely assurance case data comprising:
- means for connecting electronically an electronic intermediary to a device manufacturer, and regulatory agencies;
means for collecting electronically risk management file and safely assurance case data from said device manufacturer;
means for processing electronically said data collected from said data providers to generate and present safety assurance case;
means for electronically centralizing and maintaining the risk management file through product life cycle;
means for integrating of risk management file and safety assurance case through product life cycle;
means for electronically submitting the assurance case electronically to FDA. and other regulatory agencies or notified bodies;
means for allowing FDA to electronically manage safely assurance case reviews
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Abstract
An electronic intermediary electronically connects with a medical device manufacturer and regulatory agencies, collects and processes electronically product life cycle safely related events and information from a medical device manufacturer. The electronic intermediary processes the information collected electronically, integrates, generates, maintains, presents and distributes the risk management file and safely assurance case through the product life cycle using, linking, and connecting the collected and processed data.
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10 Claims
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1. An apparatus for collecting and processing risk management and safely assurance case data comprising:
- means for connecting electronically an electronic intermediary to a device manufacturer, and regulatory agencies;
means for collecting electronically risk management file and safely assurance case data from said device manufacturer;
means for processing electronically said data collected from said data providers to generate and present safety assurance case;
means for electronically centralizing and maintaining the risk management file through product life cycle;
means for integrating of risk management file and safety assurance case through product life cycle;
means for electronically submitting the assurance case electronically to FDA. and other regulatory agencies or notified bodies;
means for allowing FDA to electronically manage safely assurance case reviews - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
- means for connecting electronically an electronic intermediary to a device manufacturer, and regulatory agencies;
Specification