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yg385 replied to the topic "Advice before signing an NDA" – 4 months ago
@hc255 agree; I also firmly align with how you pointed out that this doesn’t necessarily have to be a scary thing. It is indeed important to ask and well understand what’s considered confidential, what are the penalties associated with breach… Read more»
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kss69 replied to the topic "Package Development Testing & Documentation" – 2 years, 1 month ago
As @ala26 mentions, I’ve seen some sterility and integrity tests as well as the burst tests referred to by@hc255. However, in my experience, I have seen additional tests that do not only comment on the integrity of the box but… Read more»
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dfn3 replied to the topic "Project Changes" – 4 years, 12 months ago
Posted by: @hc255 I’ve experienced several different kinds of changes. One change I’ve implemented several times was the change of requirements listed in our CAD drawings. I also had to change document policies within SOPs to reflect current practices. These… Read more»
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alexandrabuga replied to the topic "Package Development Testing & Documentation" – 5 years, 10 months ago
As @hc255 mentions the burst test. I actually YouTube’d different burst tests and it is has proven extremely informative and entertaining. It is really interesting to watch the video examples to see how the different testing is done. Some even… Read more»
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alexandrabuga replied to the topic "Design Validation" – 5 years, 10 months ago
Hopefully if the user needs are not met as @hc255 mentions above, they would go back to the spec and make sure the output meets the user needs and intended use. I really don’t think there is any room for… Read more»
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alexandrabuga replied to the topic Package Development Testing & Documentation in the forum Introduction to Project Management 6 years, 11 months ago
As @hc255 mentions the burst test. I actually YouTube’d different burst tests and it is has proven extremely informative and entertaining. It is really interesting to watch the video examples to see how the different testing is done. Some even just do it for the product themselves one entertaining one was for UPS “Burst Test is used to measure the…[Read more]
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alexandrabuga replied to the topic Design Validation in the forum Project Management Process and Medical Device Development 7 years ago
Hopefully if the user needs are not met as @hc255 mentions above, they would go back to the spec and make sure the output meets the user needs and intended use. I really don’t think there is any room for compromising during Design Validation, because if you end up releasing the product without addressing all these user needs, then that may cause…[Read more]
