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 […]

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All Topics, Complaint Handling and Postmarket Surveillance, ISO 13485:2016, US FDA 21 CFR Part 820 (QSR)

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 […]

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All Topics, Complaint Handling and Postmarket Surveillance, ISO 13485:2016, US FDA 21 CFR Part 820 (QSR)

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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All Topics, Complaint Handling and Postmarket Surveillance, US FDA 21 CFR Part 820 (QSR)

Table of Contents for the EU MDR 2017/745

If you have downloaded the 175-page European Medical Device Regulation PDF but are frustrated that it does not contain a Table of Contents, Oriel STAT A MATRIX has come to your rescue. We have taken the official MDR regulation as published on May 5, 2017 and added a very easy-to-navigate clickable MDR Table of Contents – all in one single PDF. DOWNLOAD THE EU MDR TABLE OF CONTENTS We’ve added internal links so you can quickly access every Chapter, Article, […]

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All Topics, EU Medical Device Regulation (MDR 2017/745)
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