Medical Device Courses | dag56 | Mentions https://medicaldevicecourses.com/members/dag56/activity/mentions/ Activity feed mentioning dag56. Fri, 24 Apr 2026 18:20:46 -0400 https://buddypress.org/?v= en-US 30 hourly 2 e4d605d426e9b64f6bad9cd09b22dea1 yg385 replied to the topic "Discussion Topic: The Fifth "P" of Marketing" - https://medicaldevicecourses.com/activity/p/29887/ Sun, 20 Oct 2024 20:10:06 -0400 @dag56 , agree using a celebrity is definitely an effective tool that’s used in todays marketing to further connect with the intended audience. Another example of a celebrity very well used in Marketing is Ryan Reynolds in Mint Mobile ads….   Read more»

]]> 3e371c31f458407121cf5b3f327c779d thuytienlecao replied to the topic "Upper vs Middle Management." - 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»

]]> 4d4ca0b26495b04be9630e174bc36f7b thuytienlecao replied to the topic "How to run a risk management meeting ?" - 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»

]]> 40d57308f116417018cc73502dadd0a0 alexandrabuga replied to the topic "Clinical Studies" - https://medicaldevicecourses.com/activity/p/13736/ Wed, 15 May 2019 17:07:46 -0400 I agree with @reshamn and @dag56 that there are many advantages to clinical trials including having patients have access to new treatments. At Sloan there are many clinical trials which include testing new drugs or drug combinations. As many have…   Read more»

]]> a8b48ec417b0418d2440e8fe4905aec6 alexandrabuga replied to the topic "Discussion Topic: Brand new biomaterial" - https://medicaldevicecourses.com/activity/p/12936/ Wed, 15 May 2019 17:00:31 -0400 As many have mentioned like @bb254 and @dag56 before testing in clinical trials many tests need to be preformed. The biocompatibility testing needs to be performed in accordance with ISO 10993 including Cytotoxicity, Genotoxicity, Irritation, Systemic Tox, Hemocompatibility, Implantation, Toxikokinetics….   Read more»

]]> 8161c6bfe08c3aaa472350aa2f952a9d thuytienlecao replied to the topic Upper vs Middle Management. in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/5348/ Mon, 27 Nov 2017 01:36:57 -0500 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 experience in middle management. Also, I have read the article that @kak33 posted and actually agree with the opinion stated in the article…[Read more]

]]> 0 1bf3e0682f95aa4ceb82da885e61a7b9 jad73 replied to the topic Upper vs Middle Management. in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/5333/ Mon, 27 Nov 2017 00:29:57 -0500 I think I can do both. I’m more suited starting out in a middle management role then transitioning to upper management. It goes in line with what @Scott said where upper managers would be best if they spent some time with the company as a middle manager. I think that being able to complete/fulfill a task on a daily/weekly basis is a fulfilling…[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 6993e683f0961a1a7a825806087f28a2 thuytienlecao replied to the topic How to run a risk management meeting ? in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/5110/ Tue, 14 Nov 2017 17:58:58 -0500 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 has mentioned. For examples, a meeting between all the engineers and scientist and PM to draw up the risks before all the…[Read more]

]]> 0 f59a0fe15dd4a320b49bd14413ccded9 alexandrabuga replied to the topic Clinical Studies in the forum Clinical Research Basics https://medicaldevicecourses.com/activity/p/4597/ Sun, 29 Oct 2017 20:22:14 -0400 I agree with @reshamn and @dag56 that there are many advantages to clinical trials including having patients have access to new treatments. At Sloan there are many clinical trials which include testing new drugs or drug combinations. As many have mentioned the patients understand the risks of entering a clinical trial, but especially in the…[Read more]

]]> 0 7fecdc643393c5400d7dcf3f90c1ef44 alexandrabuga replied to the topic Discussion Topic: Brand new biomaterial in the forum Pre-clinical Device Development https://medicaldevicecourses.com/activity/p/3391/ Thu, 21 Sep 2017 02:45:13 -0400 As many have mentioned like @bb254 and @dag56 before testing in clinical trials many tests need to be preformed. The biocompatibility testing needs to be performed in accordance with ISO 10993 including Cytotoxicity, Genotoxicity, Irritation, Systemic Tox, Hemocompatibility, Implantation, Toxikokinetics. A urinary catheter is an example of a…[Read more]

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