Medical Device Safety Monitoring and Incident Reporting

This aim of this module will cover the business and ethical responsibilities of a company following placing a medical device on the market.  The critical regulatory systems and processes which must be in place to protect patients and users.  It will include the interaction between regulators and industry in the post market phase of the medical device.  Students will be competent on the use of regulatory body databases and practiced on sample input.  The appropriate tools for vigilance decision making and safety report filing will be examined for the relevant global jurisdictions.  Understanding the management and implementation of field safety actions will be evaluated.

1. Evaluate the legal requirements relating to postmarket surveillance, vigilance and similiar reports types to ensure regulatory compliance is achieved.

2. Describe the current global requirements for medical device event reporting in line with risk level of the device.

3. Prepare incident reports for the relevant authorities, input the appropriate data to Eudamed or Maude databaes or corresponding submissions for other regions.

4. Demonstrate competency in complaint and sales data analysis to appropriately present event rate occurrence.  

5. Implement business processes to communicate safety related field actions ethically i.e. recalls. in line with regulations.