SCOPE AND OBJECTIVES
Oxford will engage in a large scale remediation project focused around customer complaints.
Oxford will look to provide a team of pre-screened consultants based on the following questions;
- How many years' experience have you reviewing "Customer" complaints?
- What products/classes of products were involved?
- What electronic systems have you use to insert the information? (e.g. SAP, Trackwise, etc.)
- How many Complaints have you reviewed in a day?
- Experience with MDD/MDR Tools?
- Experience writing Vigilance reports
- Exposure to Notified Bodies (DEKRA. TUV, BSI)
It is planned that Oxford can support the clearance of these complaints within 12 months. Naturally a certain amount of escalations / CAPA / Vigilance reports will come as a result leading to additional workstreams and needs. In tandem to clearing the backlog of complaints Oxford will recommend to harmonise the post market surveillance systems to better support the individual business units. This should help avoid any repeat and allow for sustained growth with successful product performance on the market.
- Complaint Handling
- Vigilance Reporting
- MDD/MDR tools
- Electronic Databases