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 Medical Device Complaint Investigation Procedure LEVEL I: Conduct an initial investigation Confirm the complaint. Is the alleged deficiency actually a deficiency? Do you have enough information to […]

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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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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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How Quality System Harmonization Supports Growth

quality-system-harmonization

Do any of These Quality System Challenges Sound Familiar? “Me too” nonconformances or 483 observations occurring in different areas of the business. “We do it this way” responses that differ by area when you ask employees how they execute quality system requirements. “I didn’t know that” responses when asked about an organizational quality goal. “How will we roll this out across the company?” when there is a need to transition to new requirements such as MDSAP, the new European Union […]

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