Vault Product Surveillance simplifies and standardizes postmarket surveillance for medical devices, improving product safety, reliability, and quality. An application add-on for QMS to support our Medtech / Medical Device and Diagnostics customers, Vault Product Surveillance currently supports Adverse Event Reports for FDA, Health Canada, EU MIR, and Australia/New Zealand (TGA) forms. It also supports electronic submission via gateway for eMDR records to the FDA. Future releases of this application will bring support for submissions to other health authorities to ensure timely adverse event reporting.
Features
- Global Reportability Decision Logic: Vault Product Surveillance standardizes and consolidates the complaint reportability process for various health authorities through a global decision tree, allowing organizations to define rules to automate reportability decision-making.
- Automated Adverse Event XML Payload Generation: Built-in XML payload generation provides an automatically populated electronic submission XML file for the FDA electronic medical device reporting (eMDR) form and EU MIR form.
- PDF Form Generation: Generate formatted PDF output of the reporting forms. Customers can use this feature to submit the PDF file manually to the appropriate health authorities, or to share the information within their organizations.
- eMDR XML Payload Transmission to FDA: Support for setup and transmission of eMDR XML documents through the FDA Electronic Submissions Gateway.