Medical Device Vigilance Database

Medical Device Databases | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases

Apr 6, 2022

MAUDE - Manufacturer and User Facility Device …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm

Device user facilities include hospitals, outpatient diagnostic or treatment facilities, nursing homes and ambulatory surgical facilities. Device user facilities must submit reports when …

Market surveillance and vigilance - Public Health

https://health.ec.europa.eu/medical-devices-sector/directives/market-surveillance-and-vigilance_en

Safety information | International Medical Device …

https://www.imdrf.org/safety-information

Safety information | International Medical Device Regulators Forum Safety information The following table provides links to device safety information as published by IMDRF …

Where you can find adverse event data for your device

https://www.medicaldevicesgroup.net/medical-devices/where-you-can-find-adverse-event-data-for-your-device/

The primary publicly accessible database for adverse event reporting is the US FDA MAUDE database: …

EUDAMED database - EUDAMED - European Commission

https://ec.europa.eu/tools/eudamed/

The creation of a European database on medical devices (EUDAMED) is one of the key aspects of the new rules on medical devices ( Regulation (EU) 2017/745) and in vitro …

Medical devices: guidance for manufacturers on vigilance

https://www.gov.uk/government/collections/medical-devices-guidance-for-manufacturers-on-vigilance

The manufacturer will need to ensure their device meets appropriate standards of safety and performance for as long as it is in use. The notification and …

Where do I find Adverse Event Database for Medical Devices?

https://elsmar.com/elsmarqualityforum/threads/where-do-i-find-adverse-event-database-for-medical-devices.56201/

#1 I am requiring the Adverse event database for MEDICAL DEVICES. Is there anywhere I can access this data for UK, EU and Australia which is similar to …

BfArM - Public databases

https://www.bfarm.de/EN/Medical-devices/Tasks/DMIDS/Public-databases/_node.html

Pharmacovigilance Reporting risks Risk information Periodic Safety Update Reports (PSURs) Graduated plan officer Boards and Committees Medicinal products information …

Drug and Medical Device Databases - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/drug-and-medical-device-databases.html

Purpose. The purpose of this document is to provide a comprehensive list of Health Canada’s drug and medical device databases. These guidelines are designed to …