Medical Device Courses | gh56 | Mentions https://medicaldevicecourses.com/members/gh56/activity/mentions/ Activity feed mentioning gh56. Fri, 24 Apr 2026 22:39:12 -0400 https://buddypress.org/?v= en-US 30 hourly 2 41f1bd8c48087ff2e51f3708998d15b0 thuytienlecao replied to the topic "Quality Management Principles" - https://medicaldevicecourses.com/activity/p/15729/ Wed, 15 May 2019 19:13:21 -0400 @gh56 and @merzkrashed had talked about the 3 basic concepts of QM principles: system approach, process approach, and factual approach. I would like to add on some other principles that I think are also important: 1. Customer focus: it emphasizes…   Read more»

]]> d41bda48f976a7451b8885ffb4f6568a srg36 replied to the topic "Regression Verification and Validation" - https://medicaldevicecourses.com/activity/p/14789/ Wed, 15 May 2019 19:00:04 -0400 I agree that it is important to have a good plan of how to handle testing failures when doing your V&V, but I like the points that @gh56, @merzkrashed, and @Sanam brought up, about spending more time on coming up…   Read more»

]]> 927051b27248904b5b0b8a1c12fddce8 thuytienlecao replied to the topic Quality Management Principles in the forum Quality Systems Management https://medicaldevicecourses.com/activity/p/7247/ Fri, 13 Apr 2018 20:44:50 -0400 @gh56 and @merzkrashed had talked about the 3 basic concepts of QM principles: system approach, process approach, and factual approach. I would like to add on some other principles that I think are also important:
1. Customer focus: it emphasizes that a business should understand the demand and customers’ needs and expectations. More effective…[Read more]

]]> 0 ae50989ebb1786c581eef0f7c8995dfc thuytienlecao replied to the topic Audits in the forum Quality Systems Management https://medicaldevicecourses.com/activity/p/7167/ Fri, 06 Apr 2018 21:09:48 -0400 I agree with previous comments about internal audits and would like to sum up and expand the pros and cons for this type of audits.
PROS
1. It helps compare your practices and processes against proposed prodecures and make corrections
2. It reduces the risks/chances of frauds
3. It ensures that accounting staff keep records up to date and are…[Read more]

]]> 0 47279cc8adf51414ad114057ff8dcb4e srg36 replied to the topic Regression Verification and Validation in the forum The Design History File https://medicaldevicecourses.com/activity/p/6050/ Thu, 01 Feb 2018 19:08:01 -0500 I agree that it is important to have a good plan of how to handle testing failures when doing your V&V, but I like the points that @gh56, @merzkrashed, and @Sanam brought up, about spending more time on coming up with a reasonable and appropriate value for the acceptance criteria to reduce the risk of having failures during V&V. This definitely…[Read more]

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