The New EU In Vitro Diagnostic (IVD) Regulation: What You Need to Know

In May 2016, European Union (EU) institutions agreed to draft text for the In Vitro Diagnostic Device Regulation (IVDR) that will replace the existing In Vitro Diagnostic Devices Directive (IVDD) 98/79/EC. The new regulation introduces significant changes for IVD manufacturers that currently hold a CE Mark or plan to market their products in Europe. To start getting ready, Oriel STAT A MATRIX has compiled a list of high-level compliance changes that will need to be considered. Updated IVDR Timing The […]

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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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Issues Driving the ISO 13485:2016 Revision

Standards are not revised in a vacuum. Industry changes, regulatory challenges, and feedback from medical device manufacturers, regulators, and auditors are all considered. In this two-part series, we discuss key changes to ISO 13485:2016 with Ed Kimmelman, an Oriel STAT A MATRIX Executive Management Consultant who recently retired as the Convenor of the ISO/TC 210, Working Group 1 on quality systems – the ISO working group responsible for developing ISO 13485:2016. For ISO 13485:2016, there were several issues that led […]

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