Tackling the Trouble Timeline

After devices enter the market, it is typical for manufacturers to monitor incidents and complaints and to determine if there are performance issues that are occurring at a greater than expected rate— that expected rate having been previously judged to be below an acceptable threshold. Or, an acceptable rate judgment might be newly made, especially for unanticipated problems. What, then, must follow is a sequence of steps related to investigation, determining a fix if indicated, and rolling out that fix. There must also be an ongoing consideration about what, if anything, to do about product already in use or in the pipeline. All of these technical and business decisions have a time element associated with them that must also be managed, with the general objective to move as quickly as reasonably possible. Issue identification Product issues are typically identified either from external reports or internal quality controls. For external reports, there will often be some number of incidents that occur that are noted to be more than was anticipated or more than has historically occurred. The first step in addressing problems is to have an effective process to record, note, and trend issues, whether they are direct complaints, MDRs, published papers, other field feedback, or information from other sources. What number of events triggers attention, and then action, is a local decision, which is however subject to being second-guessed. Complaint handling is a regulated process ...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news