To What Extent Should You Investigate That Medical Device Complaint?

This is the third article in a four-part series on Medical Device Complaint Handling. Download all four parts as a single PDF. Part 1: Medical Device Complaint Handling: Understanding the Basics Part 2: Is That Medical Device Incident Reportable? Part 3: This post Part 4: Medical Device Postmarket Surveillance (PMS): Building a Process LEVEL I: Conduct an initial investigation Confirm the complaint. Is the alleged deficiency actually a deficiency? Do you have enough information to investigate the complaint? Make earnest […]

Is That Medical Device Incident Reportable?

This is the second article in a four-part series on Medical Device Complaint Handling. Download all four parts as a single PDF. Part 1: Medical Device Complaint Handling: Understanding the Basics Part 2: This post Part 3: To What Extent Should You Investigate That Medical Device Complaint? Part 4: Medical Device Postmarket Surveillance (PMS): Building a Process Basic complaint-handling process Before we talk about reporting, we should take a look at the basic complaint-handling process, which has three phases. STEP […]

Medical Device Complaint Handling: Understanding the Basics

This is a four-part series on Medical Device Complaint Handling. Download all four parts as a single PDF. Part 1: This post Part 2: Is That Medical Device Incident Reportable? Part 3: To What Extent Should You Investigate That Medical Device Complaint? Part 4: Medical Device Postmarket Surveillance (PMS): Building a Process For those outside the industry, the term “complaint handling” conjures visions of angry customers arguing with tone-deaf service representatives. If you’ve ever had a dispute with your […]

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