https://medicaldevicecourses.com/members/thuytienlecao/activity/ Activity feed for thuytienlecao. Fri, 24 Apr 2026 17:20:38 -0400 https://buddypress.org/?v= en-US 30 hourly 2 487f332445aa00d9691c637f5a106213 https://medicaldevicecourses.com/activity/p/15951/ Wed, 15 May 2019 19:15:33 -0400 I agree with previous comments about the DHF being a living document. I would like to add on the previous ideas about the advantageous of it being a living document. 1. Being a living document, DHF will be updated after…   Read more»

]]> f2b19392eb8ca7914e981052e57abcf8 https://medicaldevicecourses.com/activity/p/15835/ Wed, 15 May 2019 19:14:25 -0400 I would like to add some points about shutting down/pausing studies. It doesn’t take much to make it happen. The IRB has a lot of power in this matter. My lab was in a “pause” mode for a few weeks…   Read more»

]]> e63b6d6f9630e7057c3df3fc56439265 https://medicaldevicecourses.com/activity/p/15834/ Wed, 15 May 2019 19:14:24 -0400 I would like to answer the original question and add the points about general clinical trials without the animal studies that have not been mentioned. “how can you possibly predict that beforehand”? we don’t. There can always be an unforeseeable…   Read more»

]]> a90f20e2e93954da45828b1e5f408fa5 https://medicaldevicecourses.com/activity/p/15833/ Wed, 15 May 2019 19:14:24 -0400 At the lab where I used to work, we had both prospective clinical study which is collecting data in real time or retrospective which is using old data to be analyzed. The way the studies were organized were so that…   Read more»

]]> 8550e410dc998f1e41884ce4c670c239 https://medicaldevicecourses.com/activity/p/15832/ Wed, 15 May 2019 19:14:23 -0400 I think I actually have a different opinion with you guys. I worked in clinical research for at least 2-3 years in a hospital in NJ and I wouldn’t mind working in clinical trials, maybe as a study coordinator or…   Read more»

]]> a1be0e2d380cdffe7919476e5fdcde06 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 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»

]]> 65a22268cb93e53d06f34a184ba5ccaa https://medicaldevicecourses.com/activity/p/15728/ Wed, 15 May 2019 19:13:20 -0400 hi guys, I am a bit confused about internal audit, if anyone knows, could you please clarify? In the lecture, (slide 9), it’s stated that for internal audit the company performed by itself and it’s not as serious. My question…   Read more»

]]> 6ac4e384638871bd34cac7ce94e46f8e https://medicaldevicecourses.com/activity/p/15726/ Wed, 15 May 2019 19:13:18 -0400 I agree with previous comments about Correction being the short-term solution and Corrective action, on the other hand, is a long-term solution. Correction is taken to rectify a known nonconformance and Corrective Action is taken to prevent recurrence of said…   Read more»

]]> 15ff19ff4c1c21ed1dff0c1e99276864 https://medicaldevicecourses.com/activity/p/15682/ Wed, 15 May 2019 19:12:50 -0400 Thanks for the article and info @alexandrabuga. I agree that it is logical. And it would make things simpler. Other than the points from @kak33 comment, in comparison with ISO 13485, FDA 21 CFR Part 820 QSR is the law…   Read more»

]]> e1de8ff6517f02f8e33df8fb28ed27f4 https://medicaldevicecourses.com/activity/p/15672/ Wed, 15 May 2019 19:12:45 -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…   Read more»

]]> 25be0de8c39dc3fe76ed2482c17bfce5 https://medicaldevicecourses.com/activity/p/15671/ Wed, 15 May 2019 19:12:44 -0400 I believe the above comments are solutions from the business/company admin side. To answer Fady’s question from the employee perspective, I believe the best way to communicate to management that additional resources are needed is to speak up management have…   Read more»

]]> 6a8678611215a6fe504769d30ce52c4c https://medicaldevicecourses.com/activity/p/15529/ Wed, 15 May 2019 19:07:19 -0400 Thank you for an interesting question with a lot of different views. In this unforeseeable situation, it’s difficult to say “to kill” or “not to kill”, it’s a case by case basis. And if it is “to kill”, I agree…   Read more»

]]> df6426aaa4dcf94468b33591c249658b https://medicaldevicecourses.com/activity/p/15527/ Wed, 15 May 2019 19:07:18 -0400 I agree with previous posts about funding being the key driving force to support change and innovation. I would like to add in the timing factor and market condition. A lot of time, a deadline is a strong driving force…   Read more»

]]> d430ac869330d61aac56de12424c7522 https://medicaldevicecourses.com/activity/p/15525/ Wed, 15 May 2019 19:07:17 -0400 There are three primary types of obsolescence: technical obsolescence (new technology surpasses the existing technology), functional obsolescence (when a technology can no longer be fixed//upgraded due to parts or software compatibility) and planned obsolescence (a business strategy used to increase…   Read more»

]]> 314a8ed728665b62cf854c7f633b3986 https://medicaldevicecourses.com/activity/p/15153/ Wed, 15 May 2019 19:03:30 -0400 I would like to add that it would be very costly to re-validate everything. Imagine there is mass production. This “critical machine” might have produced thousands of products if not more. I agree with most of you about the decision…   Read more»

]]> 320d6ec95b9623fb16b8412e375d6b73 https://medicaldevicecourses.com/activity/p/15152/ Wed, 15 May 2019 19:03:30 -0400 Hi, I agree with most of you about the fact that the device needs to be validated again once it’s moved because you don’t know what could have changed during the process.But depends on the condition, you may not need…   Read more»

]]> 834115dd3e40ae1d8a9ac19ab8a0904b https://medicaldevicecourses.com/activity/p/15151/ Wed, 15 May 2019 19:03:29 -0400 Some critical-process standards include a requirement for re-validation at “defined intervals”, and to require that those “intervals shall be justified”. (Language of ISO 11135-1, EtO Sterilization.) It is common in the US device industry to regard the outer limit for…   Read more»

]]> 91aac15461fcfdd0bf1fab5f23eda5c6 https://medicaldevicecourses.com/activity/p/15150/ Wed, 15 May 2019 19:03:28 -0400 I agree with @srg36 that the way to master the skill is a lot of practice and experience. I would like to add reading to that list. I took Technical Writing as an undergraduate course, I was good but not…   Read more»

]]> 9bc2a38cb4d95af80638d5456338e836 https://medicaldevicecourses.com/activity/p/15083/ Wed, 15 May 2019 19:02:53 -0400 I have never worked in the industry. With my very limited related experience, I think the best set up of QMS depends on the size and function of the company.If the company is very small, it’s ineffective to have such…   Read more»

]]> 99a6a6ac9e705e07124d67fb815dcafa https://medicaldevicecourses.com/activity/p/15082/ Wed, 15 May 2019 19:02:53 -0400 I think it’s always good to validate. I agree with @bb254 about engineers being trained per the SOP’s of the company and validating equipment. I think every employee, not just engineers should be made aware and trained in the validation…   Read more»

]]> 42ffde785f4d1cd2aad01cb8f7c56354 https://medicaldevicecourses.com/activity/p/15078/ Wed, 15 May 2019 19:02:50 -0400 I disagree with @srg36 and agree with @alexandrabuga about the need to update revision number. I think it’s needed to have all the docs updated once a revision is made. I also agree that it’s a lot of work and…   Read more»

]]> b6faf639d91c4d7ff0447984512e5f13 https://medicaldevicecourses.com/activity/p/14736/ Wed, 15 May 2019 18:59:37 -0400 I agree with opinions stated above. I believe the major challenge facing medical device regulators as well as manufacturer comes down to differentiating between combination devices that are primarily devices and those that are medicinal. This will even get harders…   Read more»

]]> d9d3fc480c77acf9220642f3b4b4a983 https://medicaldevicecourses.com/activity/p/14719/ Wed, 15 May 2019 18:59:28 -0400 I would add on to the list of various devices being classification differently between the US and EU with needle destruction devices. These are not considered medical devices in Europe but they are class III in the United States. In…   Read more»

]]> bc3f97426fedcd476bc080cac08cdb4c https://medicaldevicecourses.com/activity/p/14716/ Wed, 15 May 2019 18:59:26 -0400 My answer is maybe not. Other than the lecture video, I have limited area about this topic so I did a search on it and found some interesting information. From the lecture, various reasons you guys have mentioned and various…   Read more»

]]> 480312878e226c9102aab270687a2b92 https://medicaldevicecourses.com/activity/p/14597/ Wed, 15 May 2019 18:58:21 -0400 I agree with @alexandrabuga and @bb254 about the importance of Participation. I want to further emphasize the importance of participation, especially now in this era, participation is required to keep up with the market and maintain brand relevancy. Thanks to…   Read more»

]]> 01efe867511c0e046dfe36986c0506c3 https://medicaldevicecourses.com/activity/p/14558/ Wed, 15 May 2019 18:58:00 -0400 I agree with you guys about the facts that there is no specific “good number” in the number of centers, multi-center clinical trials (MCCT) are expensive, there are a lot of aspects involving in MCCT. There is an article named…   Read more»

]]> 900f6de76ad4d5cade7fc3a81816fb03 https://medicaldevicecourses.com/activity/p/14549/ Wed, 15 May 2019 18:57:55 -0400 I am not working in the industry but my related field is vestibular rehabilitation. Currently, the focus of the field is toward automated systems and incorporating VR into physical rehabilitation. On the software side, the devices are made so that…   Read more»

]]> 2f265eefb5dbfeb719e811a6127cb386 https://medicaldevicecourses.com/activity/p/14400/ Wed, 15 May 2019 18:55:47 -0400 I agreed with others about the differences between a patent and an NDA and how a patent gives you a legal proof of idea ownership. I would like to add to the idea of using NDA to protect ideas and…   Read more»

]]> 3c5cec58bf730b97c4f802b0d4453812 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»

]]> b07a20521b000bd33fc51dfb705952ce https://medicaldevicecourses.com/activity/p/14382/ Wed, 15 May 2019 18:55:38 -0400 Thank you for teaching this course. What I love most about it was the information-rich lessons and flexibility. The lessons were organized in separate topics and videos for each week so they are very easy to digest. I love the…   Read more»

]]> 8cf483f0182740fbc423787c1577b8f3 https://medicaldevicecourses.com/activity/p/14309/ Wed, 15 May 2019 18:54:59 -0400 Although I agree with @Adrian and many others about the matrix organization, I actually work in a small collaborating environment that use the project-based organization well. We were managed by a manager who reports to the boss. We report directly…   Read more»

]]> 3e371c31f458407121cf5b3f327c779d https://medicaldevicecourses.com/activity/p/14307/ Wed, 15 May 2019 18:54:58 -0400 I personally perfer upper management because I tend to look at things in a big picture and for long term processes and I agree with @dag56 and @scott that to be a upper manager, you should have to have certain…   Read more»

]]> 144d6a252da0a1e1bb9e9fa9f5e96375 https://medicaldevicecourses.com/activity/p/14304/ Wed, 15 May 2019 18:54:57 -0400 I was in a Matrix Organization where I had 2 direct bosses. The organization was not as clear as in the lecture that each project has a functional manager and a project manager. We typically work in various projects managed…   Read more»

]]> 4357c6a29c06343353b923606c8faed9 https://medicaldevicecourses.com/activity/p/14104/ Wed, 15 May 2019 18:51:57 -0400 I agree with other about the ISO 14971 and Yiming Chen about the key terms. I would like to elaborate on the major phases of the risk management process aligning with ISO 14971 standard (Adding on to @jtl27‘s comment). Major…   Read more»

]]> 27bf0a4329fe777da0ca8660de25beb0 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»

]]> 4d4ca0b26495b04be9630e174bc36f7b https://medicaldevicecourses.com/activity/p/14083/ Wed, 15 May 2019 18:51:45 -0400 I agree with Mark about the formality, necessity, and process of a risk and with @dag56 about profit/risk scale. I think it would also be beneficial to have prior smaller meeting building up to this big scale meeting that Mark…   Read more»

]]> 624a1c7a7c7828339a51a54989337cfc https://medicaldevicecourses.com/activity/p/13959/ Wed, 15 May 2019 17:09:53 -0400 In my opinion, I don’t agree with the previous comment If I understand correctly about numerous trials. Instead, a company/manufacturer should have an established procedures with a defined operating conditions (units, lots, time etc) like @markabdelshahed has mentioned. First of…   Read more»

]]> 5ac193cf83a93bd45a24d41403e59dc7 https://medicaldevicecourses.com/activity/p/13958/ Wed, 15 May 2019 17:09:53 -0400 HI, @Scott, I haven’t done any protocols for medical devices but in the past working in clinical settings, we have planned different protocols, proposals. We mostly used Gpower analysis to determine the amount of subjects (samples) needed for a protocol…   Read more»

]]> e025543283406db61509aaf380eeb047 https://medicaldevicecourses.com/activity/p/13957/ Wed, 15 May 2019 17:09:52 -0400 I agree with @gaberuiz13 that the tests have to make sense. Specifically, some products already have a set of “gold-standard” validation protocols to follow, such as blood pressure cuff. There are myriads of different kinds of blood pressure cuffs in…   Read more»

]]> 43b7ad8bc07f65053a577609e06668c0 https://medicaldevicecourses.com/activity/p/13859/ Wed, 15 May 2019 17:08:52 -0400 @ppp23: if you are asking about what it is, it stated on that document that “Design output means the results of a design effort at each design phase and at the end of the total design effort. The finished design…   Read more»

]]> 58d76bc4f257191b4861ca0c1b77a59d https://medicaldevicecourses.com/activity/p/13856/ Wed, 15 May 2019 17:08:51 -0400 I agree with previous comments about the need of HF. I came across this interesting situation where it seems like validation could be a bit flexible. There’s this article from Arena Solutions giving an example about Band-Aid products as a…   Read more»

]]> f7779018d72b3ad528ebf79d91584fbb https://medicaldevicecourses.com/activity/p/13853/ Wed, 15 May 2019 17:08:49 -0400 To add in @ao242 comment about ASEAN Medical Device Regulations, Vietnam is one of the countries that import a lot of medical devices. In the past (before the end of 2016), there were 2 distinct bodies of legislation—one for medical…   Read more»

]]> 4636fd7a7e3f8f468258b03fa94a193f https://medicaldevicecourses.com/activity/p/13657/ Wed, 15 May 2019 17:06:58 -0400 It’s important to have clinical trials. I agree with Mark and @reshamn on this point. I also want to point out that before going on clinical trials. The drug and medical devices being tested must have been tested intensively in…   Read more»

]]> af253f294c9c63303d145538331079b7 https://medicaldevicecourses.com/activity/p/13656/ Wed, 15 May 2019 17:06:58 -0400 I agree with @srg36 that placebos are very important. The expectation is a very powerful thing. Similar to the example Dr. Simon mentioned in the lecture, sometimes, when people call to make an appointment with a doctor/therapist, they already feel…   Read more»

]]> 6e1f54a6ad5b1b39dabe26d1183959be https://medicaldevicecourses.com/activity/p/13654/ Wed, 15 May 2019 17:06:56 -0400 I think having a clinical background is a great advantage. It may not be a necessity depending on your roles. After college, I was working in a clinical research lab in a hospital as a Research Assistant (RA) for two…   Read more»

]]> c87530a6220a8c31113363f97f22baa2 https://medicaldevicecourses.com/activity/p/13630/ Wed, 15 May 2019 17:06:43 -0400 References:
1. https://www.fastcompany.com/3060123/the-career-limitations-of-emotional-intelligence
2. https://brandongaille.com/12-pros-and-cons-of-emotional-intelligence/ (I only agree with a few points taken from this article, stated in the post).

]]> 2d6f7659b0381b77d9a5f8bc72158a38 https://medicaldevicecourses.com/activity/p/13628/ Wed, 15 May 2019 17:06:42 -0400 I agreed with previous posts (from @aaq2 & @ppp23 …) about the definition of EI, the importance of EI in marketing and Kidwell’s paper. I also think that EI is essential in marketing However, I would like to add a…   Read more»

]]> 074f7b41c893345d573240bda9786aca https://medicaldevicecourses.com/activity/p/13558/ Wed, 15 May 2019 17:06:03 -0400 I think “persuading” is “maniplulating” in some extent. As Dr. Simon mentioned in one of the lecture about the fact that when you try to sell something, you try to change the person’s mind about it. However, it doesn’t mean…   Read more»

]]> 3898d58390afe5ac9d93633b3d37d09d https://medicaldevicecourses.com/activity/p/13555/ Wed, 15 May 2019 17:06:02 -0400 **I couldn’t post the reference for some reason I have came across these grand strategies including market growth, product development, turnaround and liquidation. Market growth centralizes on expanding the market for present product. Product development relies on creating new products….   Read more»

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