Refine by
Medical Device Reporting Software
3 software items found
by:RegScan - by Enhesa based inWilliamsport, PENNSYLVANIA (USA)
The medical device reporting (MDR) requirements of 21 CFR 803 apply to manufacturers, importers, distributers, and device user facilities in the United States. Such facilities are required to report adverse device-related events to the Food and Drug Administration (FDA) or the ...
by:Honeywell | Life Sciences based inHamilton, NEW JERSEY (USA)
Medical device manufacturers must comply with 21 CFR Part 820, medical device reporting (MDR), premarket notification 510-(k), investigational device exemption, and quality system (QS) regulations. Audits help manufacturers to improve quality, lower costs, and increase compliance. ...
Manufactured by:Cisa Group S.R.L. based inLucca, ITALY
Data concerning the main cycle parameters are saved in the DataBase and can be displayed as graphs or shown in summary reports. The communication between TraceCare® and the PLC of the machines is unidirectional, so the system is able to read information from the machines but cannot send commands, thus protecting from possible alterations to the medical ...