Medical Device Courses | gdecarvalho | Mentions https://medicaldevicecourses.com/members/gdecarvalho22/activity/mentions/ Activity feed mentioning gdecarvalho. Sat, 25 Apr 2026 03:48:56 -0400 https://buddypress.org/?v= en-US 30 hourly 2 eb8ec8339be40c2dcd87f08aa3018f87 bsk32 replied to the topic "Should procedures or standards for verification and validation tests be approved by the FDA?" - https://medicaldevicecourses.com/activity/p/30763/ Mon, 17 Feb 2025 05:08:25 -0500 I agree with @gdecarvalho22 above that the FDA indirectly approves the tests as long as the final design and design process shows to comply with FDA standards. If the test parameters are not within what the company claims for either…   Read more»

]]> 2e309c21b25524b2d7eae7ea22f98915 atk27@njit.edu replied to the topic "FDA Transparency" - https://medicaldevicecourses.com/activity/p/28081/ Sat, 30 Sep 2023 18:35:23 -0400 @gdecarvalho22  You have brought up some good points that transparency of data would lead to a more thorough evaluation and benefit both companies seeking FDA approval and the public but there are potential drawbacks and challenges from this approach.  The…   Read more»

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