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There are two types of MedWatch forms: MedWatch Form 3500 and MedWatch Form 3500A. MedWatch Form 3500 represents a voluntary reporting form and should be used by consumers, healthcare professionals and patients to report serious adverse events. As stated by the FDA serious adverse events would be events related to "human medical products, including potential and actual product use errors, product quality problems, and therapeutic inequivalence/failure."
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The MedWatch Form 3500A is used specifically for formidable adverse events that result in serious injury or death. These adverse events should be reported by manufacturers, importers, IND reporters and distributors and should be documented and reported as quickly as possible. Unfortunately however, many of these incidents go unreported and can lead not only to severe fines and other punitive measures from the FDA but also to additional injuries or deaths.
MasterControl, a software company, develops technological applications that streamline and control many of the processes required for high-performance in regulated life science industries. The MasterControl eMDR™ solution allows medical device companies to streamline and automate medical device reporting and the control and quick population of MedWatch forms. To learn more about the MasterControl eMDR™ solution, contact a MasterControl representative.
In addition to the MasterControl eMDR™ solution, MasterControl provides complementary solutions for document management, PDF publishing and integrated training solutions: