Every Complaint Counts

Complaint handling that holds up: what a complaint is for your device, intake and the awareness date, the reportability decision, investigation, the risk…

This course is for the people who receive, evaluate, investigate and close complaints in a medical device company: quality managers, complaint handlers, regulatory people, service and support leads, and start-up teams setting up complaint handling for the first time. It follows a complaint from the first contact, through the decisions on whether it is a complaint, whether it must be reported and whether to investigate, to the investigation, the risk file, coding and trends, the reply to the complainant and the closure. It rests on every requirement ISO 13485 sets for complaints, on what the EU MDR, the FDA QMSR and MDSAP add, and on my experience of over 20 years, the same experience I put into the procedures I write, my articles and my trainings. Real cases from FDA warning letters and the FDA MAUDE database are told without company names.

This course is for the people who receive, evaluate and investigate complaints about medical devices, and for QA/RA managers who own the complaint handling process. It also suits customer service, field service and sales managers, who often hear about a complaint first.

Define what counts as a complaint for your device, and tell it apart from a service call or general feedback. Receive complaints from every channel on time, and record the awareness date correctly. Make the separate evaluations every complaint needs, and document each decision, including every "no". Investigate in proportion to risk, link each complaint to the risk file, and decide what follows. Code and trend complaints so that patterns show early. Reply, close and keep records, and measure the process the way an auditor will.