Medical Device Courses | merzkrashed | Mentions https://medicaldevicecourses.com/members/merzkrashed/activity/mentions/ Activity feed mentioning merzkrashed. Sat, 25 Apr 2026 00:17:23 -0400 https://buddypress.org/?v= en-US 30 hourly 2 1012c96603f536dae57be98095c27e12 mmd55 replied to the topic "Why VERIFICATION is important? and Your ideas to improve Verification process ?" - https://medicaldevicecourses.com/activity/p/23841/ Tue, 26 Oct 2021 21:33:43 -0400 Posted by: @merzkrashed According to ‘Bonezone Article – Design Verification – Validation File’, and FDA definition for Verification ‘ Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled’ So, Why do you think…   Read more»

]]> 2d5cb62dd32667216f6c4dda17a67c7e mmd55 replied to the topic "Placebo-controlled trials: Are they ethical? Are they necessary ?" - https://medicaldevicecourses.com/activity/p/23796/ Tue, 19 Oct 2021 21:17:50 -0400 Posted by: @merzkrashed As Dr.Simon mentioned about placebo-controlled trials, which is A “dummy” device or drug is used on one group of patients and compared to patients with the real one, or sometimes called a ‘sugar pill. Or a fake…   Read more»

]]> 6af4cea80e68f6d0aa96d9c2a526f171 Justinjett replied to the topic "Placebo-controlled trials: Are they ethical? Are they necessary ?" - https://medicaldevicecourses.com/activity/p/23480/ Sun, 26 Sep 2021 02:50:40 -0400 Posted by: @merzkrashed As Dr.Simon mentioned about placebo-controlled trials, which is A “dummy” device or drug is used on one group of patients and compared to patients with the real one, or sometimes called a ‘sugar pill. Or a fake…   Read more»

]]> 507b72d8d031c8e6786dba01ae884898 rajamharrison replied to the topic "Placebo-controlled trials: Are they ethical? Are they necessary ?" - https://medicaldevicecourses.com/activity/p/23459/ Sat, 25 Sep 2021 15:34:51 -0400 Posted by: @merzkrashed As Dr.Simon mentioned about placebo-controlled trials, which is A “dummy” device or drug is used on one group of patients and compared to patients with the real one, or sometimes called a ‘sugar pill. Or a fake…   Read more»

]]> 1cfb55070209f23610e859b0b8475701 jteamer replied to the topic "Placebo-controlled trials: Are they ethical? Are they necessary ?" - https://medicaldevicecourses.com/activity/p/22611/ Mon, 07 Jun 2021 00:51:50 -0400 Posted by: @merzkrashed As Dr.Simon mentioned about placebo-controlled trials, which is A “dummy” device or drug is used on one group of patients and compared to patients with the real one, or sometimes called a ‘sugar pill. Or a fake…   Read more»

]]> bbe73fe80ed94ca175a4892032d8a7a2 kc4310 replied to the topic "Academia vs. Industry Research" - https://medicaldevicecourses.com/activity/p/22480/ Mon, 17 May 2021 00:55:43 -0400 @merzkrashed great feedback.  Are you a product manager?  Some years ago I had the unfortunate experience of being apart of a product launch that was missing the product manager… I’m still not sure how that was supposed to work.  Needless…   Read more»

]]> 97fb096292bfcc89fd1d157c7ad6cc78 kc4310 replied to the topic "Academia vs. Industry Research" - https://medicaldevicecourses.com/activity/p/22479/ Sun, 16 May 2021 22:06:15 -0400 @merzkrashed great feedback.  Are you a product manager?  Some years ago I had the unfortunate experience of being apart of a product launch that was missing the product manager… I’m still not sure how that was supposed to work.  Needless…   Read more»

]]> 59b31c462833f1c578d8b5ec8c753b3c maniakberk replied to the topic "Placebo-controlled trials: Are they ethical? Are they necessary ?" - https://medicaldevicecourses.com/activity/p/20720/ Mon, 26 Oct 2020 01:55:51 -0400 Posted by: @merzkrashed As Dr.Simon mentioned about placebo-controlled trials, which is A “dummy” device or drug is used on one group of patients and compared to patients with the real one, or sometimes called a ‘sugar pill. Or a fake…   Read more»

]]> 82239d1e6e3453c3c1ab07edaeeb2959 ktk4njit-edu replied to the topic "Your Ideas about Improving Quality Control" - https://medicaldevicecourses.com/activity/p/20511/ Fri, 02 Oct 2020 13:49:43 -0400 Posted by: @merzkrashed Hi everyone, Let’s talk about how you can improve quality control department?Without quality control procedures, you could face product recalls or safety hazards that lead to expensive litigation.So, tell us about your ideas on how you can…   Read more»

]]> 9eef1030a0ceccdb8bec55e324dfb007 JordanKayal replied to the topic "Placebo-controlled trials: Are they ethical? Are they necessary ?" - https://medicaldevicecourses.com/activity/p/18919/ Sat, 26 Oct 2019 15:37:29 -0400 Posted by: @merzkrashed As Dr.Simon mentioned about placebo-controlled trials, which is A “dummy” device or drug is used on one group of patients and compared to patients with the real one, or sometimes called a ‘sugar pill. Or a fake…   Read more»

]]> a1be0e2d380cdffe7919476e5fdcde06 thuytienlecao replied to the topic "Internal Audits for small organizations" - https://medicaldevicecourses.com/activity/p/15803/ Wed, 15 May 2019 19:14:02 -0400 Thanks, @merzkrashed. Then, is it recommended to internal audit themselves and then hire an auditor?

]]> 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»

]]> 2f0d2af60dfb3632c8bdca608a7f2081 alexandrabuga replied to the topic "Process Validation vs. Verification" - https://medicaldevicecourses.com/activity/p/15312/ Wed, 15 May 2019 19:05:07 -0400 As @merzkrashed mentions the FDA “results of a process cannot be FULLY verified by subsequent inspection and test” and ISO “processes for production and service provision where the resulting output cannot be verified by subsequent monitory or measurement”. So if…   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»

]]> 3c5cec58bf730b97c4f802b0d4453812 thuytienlecao replied to the topic "Advice before signing an NDA" - https://medicaldevicecourses.com/activity/p/14383/ Wed, 15 May 2019 18:55:38 -0400 hi @merzkrashed, there are a few important points of information that if I were to sign an NDA form, I would definitely want to know in details: what information is considered confidential (definitions and boundaries), obligations/responsibilities or what might considered…   Read more»

]]> 27bf0a4329fe777da0ca8660de25beb0 thuytienlecao replied to the topic "What is Risk-benefit analysis ?" - https://medicaldevicecourses.com/activity/p/14096/ Wed, 15 May 2019 18:51:52 -0400 I would like elaborate @merzkrashed‘s point about the FDA article “Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications”. When determining risk, the FDA assessing the severity, type, frequency, and length of harmful…   Read more»

]]> 48f8e0c9f2d192c67192693199824d93 alexandrabuga replied to the topic "Design Controls in the other countries" - https://medicaldevicecourses.com/activity/p/13888/ Wed, 15 May 2019 17:09:08 -0400 It was interesting to learn as @merzkrashed mentioned that the medical devices in India are largely unregulated. I came across this article/document which mentions that this is the case due to lack of medical device specific legislation on specifying standards…   Read more»

]]> 238dcf0d4c89c12d8cf42f0b2b2d58a7 thuytienlecao replied to the topic Internal Audits for small organizations in the forum Quality Systems Management https://medicaldevicecourses.com/activity/p/7329/ Mon, 16 Apr 2018 03:18:38 -0400 Thanks, @merzkrashed. Then, is it recommended to internal audit themselves and then hire an auditor?

]]> 0 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 b19caa97917df559e58db1a8ca2cfca4 alexandrabuga replied to the topic Process Validation vs. Verification in the forum Process Validation and Process Risk https://medicaldevicecourses.com/activity/p/6722/ Sun, 04 Mar 2018 21:52:02 -0500 As @merzkrashed mentions the FDA “results of a process cannot be FULLY verified by subsequent inspection and test” and ISO “processes for production and service provision where the resulting output cannot be verified by subsequent monitory or measurement”. So if you can’t verify every requirement or verify every single item produced, process…[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]

]]> 0 d9e503f989d83510616f4424318f20eb thuytienlecao replied to the topic Advice before signing an NDA in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/5433/ Sat, 02 Dec 2017 03:48:39 -0500 hi @merzkrashed, there are a few important points of information that if I were to sign an NDA form, I would definitely want to know in details: what information is considered confidential (definitions and boundaries), obligations/responsibilities or what might considered a breach and lastly, as you have mentioned: time periods. A time period is…[Read more]

]]> 0 43004411a101158b38baffe70722517a thuytienlecao replied to the topic What is Risk-benefit analysis ? in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/5128/ Fri, 17 Nov 2017 14:51:36 -0500 I would like elaborate @merzkrashed‘s point about the FDA article “Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications”.
When determining risk, the FDA assessing the severity, type, frequency, and length of harmful events. In addition, the FDA will also evaluate other…[Read more]

]]> 0 445d30934ce40cfff21ebe2b60e7cb53 alexandrabuga replied to the topic Design Controls in the other countries in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/4896/ Sun, 05 Nov 2017 23:40:12 -0500 It was interesting to learn as @merzkrashed mentioned that the medical devices in India are largely unregulated. I came across this article/document which mentions that this is the case due to lack of medical device specific legislation on specifying standards of safety and quality for most medical devices. However this expected to change with the…[Read more]

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