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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How Quality System Harmonization Supports Growth


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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ISO 13485:2016 — Applying the Updates

In part two of our conversation with Ed Kimmelman – a member of the ISO working group responsible for developing ISO 13485:2016 and an Oriel STAT A MATRIX Executive Management Consultant – we discuss applying the ISO 13485:2016 changes in your organization. Read Part I: Issues Driving the ISO 13485:2016 Revision. Which of the major changes in ISO 13485:2016 do you think the industry needs to make a priority? The change introduced in ISO 13485:2016 related to risk-based decision making […]

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ISO 13485:2016 and ISO 9001:2015: Are They Aligned?

Decades ago, the concept of alignment didn’t arise often. There were not enough widely adopted industry standards to worry about alignment. But today we are moving in the right direction with the widespread – often required – use of global standards. Now we need to consider alignment when we compare revised versions of standards against their predecessors or related standards. What do we mean by alignment? A traditional dictionary definition of alignment is “the proper positioning or state of adjustment […]

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