Review and Evaluate complaints to determine whether an investigation is necessary. • Any alleged complaint involving possible failure of a device or labeling/packaging to meet any of its...

Oct 21, 2020 · Free template for medical device complaints that manufacturers can use to streamline and improve this quality event process.

Medical device complaint This form will be used to document all complaints regarding medical devices.

Was the device being used for diagnosis or therapy when the failure occurred?

Complete Medical Device Complaint Form online with US Legal Forms. Easily fill out PDF blank, edit, and sign them. Save or instantly send your ready documents.

This form is used by medical device users in government or private institutions to report safety and performance issues of medical devices under the Medical Device Act of 2012.

May 18, 2025 · Developing a standardized form for reporting product issues is crucial for effective post-market surveillance. A well-designed template ensures consistent data collection, facilitates …

This complaint form is used to document product defects. The complaint form contains fields for the affected device or part, customer information and containment and corrective actions.

Mar 27, 2025 · Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

To open your medical device complaint form, upload it from your device or cloud storage, or enter the document URL. After you complete all of the required fields within the document and eSign it (if that …