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Josh started the topic Discussion Topic: To trial or not to trial in the forum Introduction to Project Management 9 years, 2 months ago
Take a look at the lecture where it talks about Design Validation. In your words, what is Design Validation? In the following examples, do you think that the device would need a clinical trial as part of Design Validation or not? State your reasons.
1) A diagnostic microscope slide that determines the presence of certain stem cell markers.
2) An implantable bone plate
3) An antimicrobial suture
4) An ergonomic knee brace
Keep in mind that we might all have different answers, and that is ok. We argue about these things in real life too. What is important is that you justify your answer using the definition of Design Validation and any prior examples you might come across.