{"id":17812,"date":"2021-04-14T10:23:43","date_gmt":"2021-04-14T08:23:43","guid":{"rendered":"https:\/\/www.thema-med.com\/?page_id=17812"},"modified":"2023-06-23T12:56:50","modified_gmt":"2023-06-23T10:56:50","slug":"us-electronic-medical-device-reporting-service","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/en\/services\/local-representative-and-license-holder\/us-electronic-medical-device-reporting-service\/","title":{"rendered":"US ELECTRONIC MEDICAL DEVICE REPORTING SERVICE"},"content":{"rendered":"
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US Electronic Medical Device Reporting service <\/em><\/figcaption><\/figure>\n<\/div>\n<\/p>\n

Thema offers the US Electronic Medical Device Reporting<\/strong> service for Manufacturers of Medical
Devices (MD) and in Vitro Diagnostic Medical Devices (IVD) already
marketing in the U.S.A.<\/p>\n<\/p>\n

Thema specialists provide support in reporting adverse events or potential events to be reported where there is evidence suggesting that the device may have contribute to the death or serious injury of the patient, or when malfunctions of the device or recurrences of the same could have caused death or serious injury to the patient, as compulsorily required by the Food and Drug Administration (FDA).<\/p>\n<\/p>\n

According to the Medical Device Reporting: Electronic Submission Requirements, FDA requires Manufacturers of Medical Devices and IVDs to submit adverse event reports in electronic format (Electronic Medical Device eMDR Reporting) in order to be able to monitor device problems in the after-sales phase.<\/p>\n<\/p>\n

To assist you with these demanding obligations, Thema can assume the role of your US Electronic Medical Device Reporting delegate, in order to provide you with full support in the activities required by FDA.<\/p>\n<\/p>\n

If you subscribe the US Electronic Medical Device Reporting service, you can enjoy the following benefits:<\/p>\n<\/p>\n