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What is the design control process and how has it changed?
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@imedzavani3759 2 жыл бұрын
Rob! The Best as always :)
@MedicalDeviceAcademy 2 жыл бұрын
Thank you.
@edpalen5295 4 ай бұрын
isn't it 13485 instead of ISO 1345?
@MedicalDeviceAcademy 4 ай бұрын
The particular video you commented on is actually about IEC 62304 and how design controls have changes as agile has be adopted. Most companies now think in terms of the V-diagram instead of the Waterfall diagram for software development. You are correct that the quality system standard is ISO 13485:2016, but I think I probably did not say it clearly enough or spoke too quickly. I also referenced ISO 9001:2015 which is a general quality system standard.
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