Medical Device Courses | smk45 | Mentions https://medicaldevicecourses.com/members/smk45/activity/mentions/ Activity feed mentioning smk45. Fri, 24 Apr 2026 23:19:41 -0400 https://buddypress.org/?v= en-US 30 hourly 2 77136c6177cfba4541d418782e4b8045 Justinjett replied to the topic "Design Verification & Validation" - https://medicaldevicecourses.com/activity/p/23523/ Thu, 30 Sep 2021 03:07:47 -0400 Posted by: @smk45 While watching this week’s lecture on design control, I tried to figure out the main difference between Design Verification and Design Validation. Both are used to make sure that the design outputs align with the design inputs….   Read more»

]]> 797e8b68b6454e2579bb5a137716dd39 jailynp26 replied to the topic "Design Verification & Validation" - https://medicaldevicecourses.com/activity/p/23496/ Mon, 27 Sep 2021 00:09:50 -0400 Posted by: @smk45 While watching this week’s lecture on design control, I tried to figure out the main difference between Design Verification and Design Validation. Both are used to make sure that the design outputs align with the design inputs….   Read more»

]]> fe6a2d6d29185228e61ffbfc36c191ea jteamer replied to the topic "Risk Management Mistakes" - https://medicaldevicecourses.com/activity/p/22684/ Wed, 16 Jun 2021 03:05:53 -0400 Posted by: @smk45 I came across an article online that highlights 4 reasons why a company’s risk management approach may be wrong. It was an interesting read and indicates the following as major errors: 1. Risk management and design controls…   Read more»

]]> 477e29aef5bdc8ae09ea8795f17af437 mrlee5 replied to the topic "Determining project priority" - https://medicaldevicecourses.com/activity/p/21675/ Sat, 13 Mar 2021 23:44:43 -0500 @smk45 summed it up well. Having a good understanding of projects priority will likely impact the success of the project and overall team response.  It is important for project managers to communicate urgent tasks and ensure that the entire team…   Read more»

]]> fc30fa0aa5b77e51ab41ffa9f73c8931 Naglaa Hemida replied to the topic "Pros and Cons of the 3 Organizational Structures" - https://medicaldevicecourses.com/activity/p/21320/ Tue, 09 Feb 2021 02:45:23 -0500 Posted by: @smk45 This week’s lecture describes that there are 3 different organizational structures: functional, projectized, and matrix organizations. Each organizational structure greatly impacts the way the company manages projects and how employees work. What do you think are some…   Read more»

]]> 984d73c85f931e84ace05c02348b48f0 JordanKayal replied to the topic "Design Verification & Validation" - https://medicaldevicecourses.com/activity/p/19022/ Fri, 08 Nov 2019 22:49:51 -0500 Posted by: @smk45 While watching this week’s lecture on design control, I tried to figure out the main difference between Design Verification and Design Validation. Both are used to make sure that the design outputs align with the design inputs….   Read more»

]]> 9a9dd3a2e69af6b9eb2b46a7ef3dd943 alexandrabuga replied to the topic "Risk Management Mistakes" - https://medicaldevicecourses.com/activity/p/14108/ Wed, 15 May 2019 18:51:59 -0400 I agree that #4 “Risk management is not a lifecycle process” and that it is a mistake to think that once the development process is completed that the risk management documentation ends. I agree with @smk45 that it should be…   Read more»

]]> c4fac40771e73a730448c68cc0ed1b89 alexandrabuga replied to the topic Risk Management Mistakes in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/5142/ Sat, 18 Nov 2017 22:17:45 -0500 I agree that #4 “Risk management is not a lifecycle process” and that it is a mistake to think that once the development process is completed that the risk management documentation ends. I agree with @smk45 that it should be treated as a “living” document. As Dr. Simon discusses in lecture there should risk management documents in DHF: Risk…[Read more]

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