Wu, FuBin

Description: Temporary use of online, non-downloadable software for data collection, facilitating and generating medical device documentation and medical device development documents for managing medical device safety risk and assurance cases

Description: Binoculars; Spyglasses; Body-tubes for telescopes; Devices for wireless radio transmission; Distance measuring apparatus; Hunting binoculars; Night vision goggles; Opera glasses; Telescopic gun sights; Thermal imaging cameras

Description: Providing temporary use of non-downloadable computer software to facilitate the medical product quality management system activities, generate and maintain associated documentation reports and records

Description: Computer software for quality management system with following functionality and use: 1. Information system to define, track, and maintain the risk management activities, results and residual risks through the product life cycle: pre-market risk management activities, post-market risk management activities, production and post-production information. 2. Automatically integrates and synchronizes the safety assurance case and risk management file; automatically generates the safety assurance case out of risk management file. 3. Electronic information management system for development, review, and maintenance of safety assurance case through the product life cycle