Difference between revisions of "Medical Device System"
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Revision as of 12:21, 2 May 2022
Medical Device System (MDS)
The Medical Device System (often abbreviated to MDS) is the data base and graphical user interface used to house medical device program related data such as companies, company contacts, applications for authorization, lists of devices, and more. It is also the source of the data for the Medical Devices Active Licence Listing (MDALL), the outwardly visible database of licensed devices.
The MDS is divided up into sections; this related mostly to the function, but there is substantial communication between the sections (e.g., while the Company section maintains information about companies, other sections like Applications or Incidents will refer to the company entries.)
History
Prior to April 2018, the MDS was run on HP PowerHouse, and this interface and system was rather dated and due to the departure of staff knowledgeable about the language, impossible to update and maintain. The system had been labeled a legacy system that required replacement. In April 2018, the new interface was launched, an HTML5 web-based interface that was more modern and allowed continued development. The system runs on a Oracle database - it was on version 11g for many years and was updated in 2021 to Oracle 19c.
Interface sections
- Device - for maintaining device information
- Company - for maintaining company information
- Meeting
- Application- for maintaining application information
- Special Access - for maintaining information relevant to Special Access Program requests for medical devices
- Correspondence - for maintaining correspondence records
- Quality System
- Batch - used to launch batch processes for administrative closure of incidents
- Incident - for tracking complaints, recalls, and reported medical device problems (Some of these were migrated to the Canada Vigilance ArisG system in February 2020)
- Establishment - for establishment information
- Maintenance
- Logout - log out of the system