Medical Device Courses | chk9 | Activity https://medicaldevicecourses.com/members/chk9/activity/ Activity feed for chk9. Sun, 15 Nov 2026 11:42:43 -0500 https://buddypress.org/?v= en-US 30 hourly 2 27627b440b733304157c5df9213db8de chk9 replied to the topic "The importance of design changes and documentation" - https://medicaldevicecourses.com/activity/p/60139/ Fri, 06 Nov 2026 23:01:28 -0500 I agree that small design changes can have some of the biggest impacts on a medical device. One of the best ways to determine the effects are through risk assessment testing. Engineers should determine the results of each change and…   Read more»

]]> 6a8c0694bbed884c275000a8f5386c58 chk9 replied to the topic "Why Packaging and Labeling Matter in Medical Devices" - https://medicaldevicecourses.com/activity/p/60138/ Fri, 06 Nov 2026 22:47:20 -0500 Packaging should be consider as equally important as the medical device itself. Even if the medical device meets all its specifications, it can be damaged in transport. Damaged medical devices are susceptible to contamination or alter the functionality of the…   Read more»

]]> 1c2e43c38b9a577e3aed6e6f01dc7478 chk9 replied to the topic "When meeting the Spec is not Enough: Verification vs. Validation" - https://medicaldevicecourses.com/activity/p/60137/ Fri, 06 Nov 2026 22:29:56 -0500 I think both verification and validation are important and one cannot exist without the other. Verification goes in hand with validation as if its not in the proper technical specifications it may not work properly. Some things may need to…   Read more»

]]> db42330fb87abbb885f149a7eda018f6 chk9 replied to the topic "FDA biased?" - https://medicaldevicecourses.com/activity/p/58818/ Mon, 28 Sep 2026 19:50:19 -0400 I understand everyone’s thought that FDA is biased toward companies that pay them for expedited review, however, I think there are several misconceptions and also poor structure setup that attribute to this notion that “big pharma” or major corporations run…   Read more»

]]> 86790fe8b89ea578dc58cc6f4a7d940c chk9 replied to the topic "Medical Device Classification" - https://medicaldevicecourses.com/activity/p/58816/ Mon, 28 Sep 2026 19:10:44 -0400 [quote data-userid=”35393″ data-postid=”24219″] One thing that I think could fit under this category are certain diagnostic tests that are currently listed as Class III. I think over time, some of these tests should be reconsidered to join Class II. This…   Read more»

]]> cb0eb547ee873251e21bb5cf837dbecf chk9 replied to the topic "Can Product Claims Make Things More Complicated?" - https://medicaldevicecourses.com/activity/p/58814/ Mon, 28 Sep 2026 18:33:40 -0400 From my experience in industry I think making as little claims as possible is the ideal way to go. Anything that doesn’t support the main claim or function of a product should be avoided and wording is key. For example,…   Read more»

]]> 886382b4d88402f8a2579af364ed9e3f chk9 became a registered member https://medicaldevicecourses.com/activity/p/56987/ Fri, 04 Sep 2026 15:39:12 -0400 0