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tm422 replied to the topic "The Importance of the Design History File (DHF) in Regulatory Compliance" – 1 month, 4 weeks ago
@bryan-xavier Hi Bryan! I certainly agree. Utilizing a traceability matrix is a fantastic method to keep organization in the Design History File (DHF), I found it quite useful when organizing one for a previous semester project. It guarantees a systematic… Read more»
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jrc99 replied to the topic "Caution with Medical Devices that Require a PMA" – 2 months ago
@bryan-xavier Your information about the Breakthrough Devices Program definitely changed my own view about this topic I created. When I found out about this certain predicament from Dr. Simons lecture, my thoughts were pretty set on that medical device innovation… Read more»