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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