MedWatch Form

MedWatch Form is Specially Designed by MasterControl to Cater Medical Device Reporting requirements

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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MasterControl eMDR

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Hundreds of companies around the world use MasterControl to automate core business processes and document management activities to promote collaboration, improve decision making, and accelerate time to market.

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Free Resources

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Analyst Report: A Road Map for Addressing Quality and Manufacturing Challenges in Life Sciences (LNS Research)
Data Sheet: MasterControl eMDR
Kit: 11 Free Resources to Boost Your Medical Device FDA Readiness
White Paper: Most Common Reasons for FDA Form 483 Observations and Warning Letters in Medical Device Environments
Trend Brief: 2024 Medical Device Industry Trends

MedWatch Form 3500A

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 eMDR™ and MedWatch Forms

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.

MedWatch Form Streamlines Adverse Event Reporting

In addition to the MasterControl eMDR™ solution, MasterControl provides complementary solutions for document management, PDF publishing and integrated training solutions: