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Medical Device Reporting Software In North America

2 software items found
In North AmericaAvailable In North AmericaNear North America

RegScan - Version MDR - Medical Device Reporting System

RegScan - Version MDR - Medical Device Reporting System

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 ...
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Sparta - Medical Audit Management Softwares

Sparta - Medical Audit Management Softwares

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. ...
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