Medical Device Courses | hc255 | Mentions https://medicaldevicecourses.com/members/hc255/activity/mentions/ Activity feed mentioning hc255. Fri, 24 Apr 2026 18:20:46 -0400 https://buddypress.org/?v= en-US 30 hourly 2 56e5d5a423f7c7548ada6228bbfb95c5 yg385 replied to the topic "Advice before signing an NDA" - https://medicaldevicecourses.com/activity/p/30359/ Mon, 02 Dec 2024 04:30:32 -0500 @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»

]]> 29c56a5998a82077469e74458d3adbd1 kss69 replied to the topic "Package Development Testing & Documentation" - https://medicaldevicecourses.com/activity/p/26564/ Wed, 08 Feb 2023 22:56:05 -0500 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»

]]> 1336201cf146a495c3aa75aee39c9bd8 dfn3 replied to the topic "Project Changes" - https://medicaldevicecourses.com/activity/p/19817/ Thu, 09 Apr 2020 06:15:00 -0400 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»

]]> 259ca26b573767d1f1ed9cabf3784d22 alexandrabuga replied to the topic "Package Development Testing & Documentation" - https://medicaldevicecourses.com/activity/p/16054/ Wed, 15 May 2019 19:16:36 -0400 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»

]]> 93e269b11b2b9d026336cba769f924d4 alexandrabuga replied to the topic "Design Validation" - https://medicaldevicecourses.com/activity/p/15402/ Wed, 15 May 2019 19:05:56 -0400 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»

]]> 3610d35a67251a7fa3bf8f472fe2c578 alexandrabuga replied to the topic Package Development Testing & Documentation in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/7635/ Sun, 06 May 2018 19:12:44 -0400 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]

]]> 0 5df944c2635f2edad29d45034583bdf2 alexandrabuga replied to the topic Design Validation in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/6826/ Sun, 11 Mar 2018 20:01:21 -0400 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]

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