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Safety evaluation of a Medical Device Data System
- https://pubmed.ncbi.nlm.nih.gov/23367271/
- We conducted a series of tests examining the changes in network performance when the BedMaster system was on our isolated patient monitor network. We found that use of BedMaster led to measurable, but trivial increases in network traffic and latency. We did …
MDDS Rule | FDA - U.S. Food and Drug Administration
- https://www.fda.gov/medical-devices/medical-device-data-systems/mdds-rule
- CDRH evaluates such post-amendment devices to establish the appropriate degree of regulatory controls needed to provide reasonable assurance of their safety and …
Medical Device Data Systems | FDA
- https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/medical-device-data-systems
- Medical Device Data Systems (MDDS) are hardware or software products intended to transfer, store, convert formats, and display medical device data. A MDDS …
Medical Device Data Systems, Medical Image Storage …
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-data-systems-medical-image-storage-devices-and-medical-image-communications-devices
- This guidance was revised through a minor update to reflect amended medical device classification regulations following the issuance of the final rule, “Medical …
Medical Device Safety | FDA - U.S. Food and Drug …
- https://www.fda.gov/medical-devices/medical-device-safety
- Medical Device Safety | FDA Medical Device Safety The FDA monitors …
Medical Device Cybersecurity: What You Need to Know
- https://www.fda.gov/consumers/consumer-updates/medical-device-cybersecurity-what-you-need-know
- Protect your device and personal information: Use good password practices for your device. Create a unique password and do not share it with others. Keep your …
Safety evaluation of a Medical Device Data System
- https://www.semanticscholar.org/paper/Safety-evaluation-of-a-Medical-Device-Data-System-Liddle-Grover/6c990da34c13009300adab4b60cef0a82efa8c3a
- We conducted a range of tests to confirm the safety of deploying BedMaster (Excel Medical Electronics, Jupiter FL, USA), which is third-party software sold expressly to provide …
Device Evaluation - ECRI
- https://www.ecri.org/components/HDS/Pages/default.aspx
- Why One Member Chooses to Work with Device Evaluation. ECRI Institute's reports and device evaluations, analyses, product safety alerts, and data on incidents and adverse …
Safety evaluation of a Medical Device Data System
- https://www.researchgate.net/publication/235388274_Safety_evaluation_of_a_Medical_Device_Data_System
- We conducted a range of tests to confirm the safety of deploying BedMaster (Excel Medical Electronics, Jupiter FL, USA), which is third-party software sold expressly …
23 Registries for Medical Devices - NCBI Bookshelf
- https://www.ncbi.nlm.nih.gov/books/NBK208640/
- A standard minimum data set targeted toward device registries would be useful to support strong registry designs and to facilitate linkages with other data sources. The definition and validity of device performance issues is …
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