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Medical Device Manufacturer Software In Usa
6 software items found
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 ...
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 device ...
by:MasterControl, Inc based inSalt Lake City, UTAH (USA)
Small Medical Device Companies Can Now Manage and Automate their Design Control Process to Ensure Compliance with 21 CFR Part 820 with the Help of MasterControl's Design Control Software Systems at a Low Monthly Cost. Each manufactured medical device must be supported by appropriate documentation which ...
by:MasterControl, Inc based inSalt Lake City, UTAH (USA)
Document change control software is essential for ensuring compliance and managing change in regulated industries such as life sciences and manufacturing. By utilizing this software, companies can effectively address the complexity of change control and streamline their ...
Manufactured by:Nextern Inc based inWhite Bear Lake, MINNESOTA (USA)
We are your sole partner to provide seamless connected medical device development solutions. Leveraging our experience and expertise in medical device design, cloud architecture, and mobile engagement ...
by:AWS Truepower, LLC based inAlbany, NEW YORK (USA)
Discover how our validated, FDA CFR Part 11 compliance training management system helps you comply with evolving FDA Regulations. Keep your workforce up to date. Medical device and pharmaceutical manufacturers trying to keep up with ever-changing regulations have a tough job. Medical technology advances quickly, and with it the ...