https://medicaldevicecourses.com/members/pjf22/activity/ Activity feed for Pedro F.. Sat, 25 Apr 2026 04:09:50 -0400 https://buddypress.org/?v= en-US 30 hourly 2 873f433e764709c824db26a65905a245 https://medicaldevicecourses.com/activity/p/21078/ Tue, 08 Dec 2020 02:43:16 -0500 Due to the importance of the NDA and the terms it mandates it is important to fully understand and be in agreement with whatever you are signing. I also agree with seeking legal help to fully understand the terms you…   Read more»

]]> 542d9b667434e5d87798ec7f7bb06e21 https://medicaldevicecourses.com/activity/p/21077/ Tue, 08 Dec 2020 01:20:17 -0500 Although I agree with some of the point mentioned by you guys, but is there more information regarding the job firing? Is it due to poor performance, disciplinary action or simply because they wanted too? I dot think this is…   Read more»

]]> a9389f39b4c67fbdec4be4c81ffb52ac https://medicaldevicecourses.com/activity/p/21076/ Tue, 08 Dec 2020 01:20:16 -0500 Although I agree with some of the point mentioned by you guys, but is there more information regarding the job firing? Is it due to poor performance, disciplinary action or simply because they wanted too? I dot think this is…   Read more»

]]> 32695cd06ee29dc68e39989ff78779a0 https://medicaldevicecourses.com/activity/p/21005/ Mon, 23 Nov 2020 03:09:47 -0500 Since we are on the topic of company organization, structure, and managerial hierarchy I think this topic applies. In my company there is a functional organization structure, where all employees answer to a supervisor, they answer to managers, and they…   Read more»

]]> ba30eda88b97bd9312fdbd4eaad1100e https://medicaldevicecourses.com/activity/p/21003/ Mon, 23 Nov 2020 02:27:03 -0500 I can not decide on which organization structure is the best. Dr. Simon mentioned pros and cons for each, so I think the best approach is to have a combination of two; a project based and matrix organization. I can…   Read more»

]]> 311d8dfdeed13b87d1096a29a57fb2d3 https://medicaldevicecourses.com/activity/p/21000/ Mon, 23 Nov 2020 01:42:07 -0500 I agree with @sts27, in the sense that both upper and middle management have overlapping functions and similar skill sets. However, I think there is a difference in tasks, while upper managements is involved with the progression of the company…   Read more»

]]> 78f5d33004e0e2967d3c665a44473ec3 https://medicaldevicecourses.com/activity/p/20954/ Mon, 16 Nov 2020 04:56:12 -0500 Yes, I agree with you. Like the DDP and many other documents, the Risk management documents must be updated on a regular basis throughout the entire of device development since all risks may not have been proposed of thought of…   Read more»

]]> 54a75e0fc0a600515e983c5c726ea4f7 https://medicaldevicecourses.com/activity/p/20953/ Mon, 16 Nov 2020 04:50:25 -0500 Like many of you stated, post-market risk management is extremely important for any device, biologic, or any invention for that matter. It assures longevity of the device and evaluates risks that may not have been seen during planning, design, fabrication,…   Read more»

]]> 12abaebc2649c74f0f8a6f92935ed4cd https://medicaldevicecourses.com/activity/p/20952/ Mon, 16 Nov 2020 04:45:32 -0500 When performing the Risk Assessment of a new medical device, I think all three tools serve a purpose and can potentially identify risks that the other do not. I also believe that each tool can be used in different stages….   Read more»

]]> d057a2db242f6c78b6c758ef13c87090 https://medicaldevicecourses.com/activity/p/20854/ Mon, 09 Nov 2020 02:24:59 -0500 Interesting posts. I agree with many of you in regards to the importance to diligent record keeping and constant updating the DHF. It is in fact a “living document” as it was pointed before and will need continuous upkeep to…   Read more»

]]> bee57c3a580c2d73830593e4ca846c3f https://medicaldevicecourses.com/activity/p/20847/ Mon, 09 Nov 2020 01:25:02 -0500 As pointed out by Dr. Simon if a medical device is a component and not directly used by the patient then the user needs and the specifications are essentially the same thing and design validation is not necessary for that…   Read more»

]]> 1a428b9d978dc99226ce022fbc1173d5 https://medicaldevicecourses.com/activity/p/20845/ Mon, 09 Nov 2020 01:14:01 -0500 I agree with many of you regarding the importance of design control for the benefit of the not only the patient, but also the company developing the device. Documentation regarding changed in design, implementation of the device, and even new…   Read more»

]]> 3920d98d23ee2cf3a1c9c584e2cc7990 https://medicaldevicecourses.com/activity/p/20785/ Mon, 02 Nov 2020 01:16:16 -0500 I have very little experience on this topic, therefore it was very good and informative to read your comments and experiences designing statistical parameters for testing controls. The only experience related to this that I have is meeting manufacturer standards…   Read more»

]]> b36c171640f4e8138714b91ec0d79f24 https://medicaldevicecourses.com/activity/p/20781/ Mon, 02 Nov 2020 00:44:09 -0500 An example I can think that would require many different validation processes in order verify that it is doing what its supposed to is an artificial heart valve. The valve must have been tested in the laboratory to mimic its…   Read more»

]]> f0effb0444c96d728bab41e219626ad6 https://medicaldevicecourses.com/activity/p/20779/ Mon, 02 Nov 2020 00:29:44 -0500 This is a very interesting post since I do not have much experience with this topic. I have been involved in validations and the development of laboratories by acquired CLIA and others, but have not had the chance to work…   Read more»

]]> 76d601bf20f0f804e0dc72cb7f92acb5 https://medicaldevicecourses.com/activity/p/20717/ Sun, 25 Oct 2020 21:14:07 -0400 This is an interesting topic and it is also interesting to see that some people chose the Utilitarianism approach, where the “justified” scarifies of life is thought to be okay, as long as it served a higher purpose of benefiting…   Read more»

]]> 6252168342a8ab7ee93d19f209fe74ad https://medicaldevicecourses.com/activity/p/20715/ Sun, 25 Oct 2020 19:39:06 -0400 This is indeed a sensitive topic since are dealing with the death of a person, however, before accusing someone, an investigation must take place to evaluate the root cause of death. Also, the question itself is very vague; are we…   Read more»

]]> 102a14ccaed515422c93969c81269e7c https://medicaldevicecourses.com/activity/p/20714/ Sun, 25 Oct 2020 19:27:17 -0400 There are pros and cons for these types of studies. Like you mentioned, they are able to gather a lot more clinical evidence in a shorter time than a single trial and can encompass a larger number of patients that…   Read more»

]]> fbc5b4d979fcf57efb61d231c86685f4 https://medicaldevicecourses.com/activity/p/20676/ Mon, 19 Oct 2020 03:53:06 -0400 @maniakberk You present a good point in portraying a limitation on the degree of relevance of EI to other markets. However, from reading the article I think the main point of EI being an essential part to customer retention and…   Read more»

]]> f21d53a8e2926dad48bea2bd8c74eabc https://medicaldevicecourses.com/activity/p/20675/ Mon, 19 Oct 2020 03:30:58 -0400 Both Project management and sales need to work hand in hand to make a good sale, meet quotas, and maintain company stability. However, these are completely separate roles. As Dr. Simon described it, QA PM is like a mini CEO…   Read more»

]]> cf8226ca098cd48e05fb0ca3dcc9721d https://medicaldevicecourses.com/activity/p/20674/ Mon, 19 Oct 2020 03:20:43 -0400 From reading the posts it seems that many relate the term “manipulation” to have a negative connotation or a way to trick the customer into purchasing a bad product. I do not think think that is the case for most…   Read more»

]]> c74b438a5064ddaac93f2c16091d5b84 https://medicaldevicecourses.com/activity/p/20588/ Sun, 11 Oct 2020 10:30:06 -0400 Given the current situation we are in with the interest rates as low as 2.5% for the purchase of new homes, this subject could not be more relevant. At this time we are able to purchase a home with as…   Read more»

]]> 46f25ddd7fef0d2c0a98c95c80b329f7 https://medicaldevicecourses.com/activity/p/20587/ Sun, 11 Oct 2020 10:02:28 -0400 Form Dr. Simon’s lecture and from what most of you have written, it seems that the biggest difference is how the shares are publicly available or trading for public companies and not for private. Moreover,  where the income comes from…   Read more»

]]> 2832d72b8d783a1117a4c9a540be1a5e https://medicaldevicecourses.com/activity/p/20586/ Sun, 11 Oct 2020 09:27:26 -0400 Like many have stated above, I do not believe the choice of which type of company to create will highly impact the profit or success of the business. A more relevant point to look at would be the number of…   Read more»

]]> c344128375b2364195627f4f1b29ff86 https://medicaldevicecourses.com/activity/p/20542/ Mon, 05 Oct 2020 01:21:04 -0400 I do not see how there is actually an argument in this post about QA and ethics? It is basically unethical to not adhere to QA standards. Coming from a clinical laboratory that tests for cancer diagnostics, I do not…   Read more»

]]> 549f681360a62aa6f5ed4afd810ca141 https://medicaldevicecourses.com/activity/p/20540/ Mon, 05 Oct 2020 01:12:37 -0400 I think some of the skills that a QC engineer must have are usually part of the important core of skills that all workers should have; attention to detail, investigational and research skills, organization and diligence, work well with different…   Read more»

]]> 7883659f8a2e0fa36d2a9c8624fb999a https://medicaldevicecourses.com/activity/p/20539/ Mon, 05 Oct 2020 01:03:23 -0400 I can see that may of you have favored the initials student’s post about the “Evil-Big Pharma”, well I can say that I agree to an extent. I can see how the endless circle of treating a disease opposed to…   Read more»

]]> dae018d130f66e0bace4c172df2ba61a https://medicaldevicecourses.com/activity/p/20482/ Mon, 28 Sep 2020 03:39:29 -0400 In my field, I have been lucky enough to work with people from very different cultural backgrounds, ethnicities, work occupations, and background. In my view, it is always a plus to engage with someone that is the most unlike you…   Read more»

]]> c6fc42a9f24d2b6cdb20eeae1de24e5c https://medicaldevicecourses.com/activity/p/20479/ Mon, 28 Sep 2020 03:25:41 -0400 I would have to agree with @jonwil123 here. I see the importance in having the 501K approval for some devices that have proven enough clinical significance as an old one. Perhaps the same company that released the device 40 years…   Read more»

]]> 45db4c6fcc1cbdbb7a89794b23d178df https://medicaldevicecourses.com/activity/p/20477/ Mon, 28 Sep 2020 03:18:54 -0400 This is an interesting topic and your experiences with a team making the recall or preparing to counter the recall are very informative. After reading some of the post, it seems that devices tend to always have some kind of…   Read more»

]]> 9047108f88596103a2e4e3037de58088 https://medicaldevicecourses.com/activity/p/20404/ Mon, 21 Sep 2020 01:38:50 -0400 Like many of you have mentioned there are pros and cons for both. I think that both could be demanding and rewarding at different times. In the industry, you will always have someone overseeing what you are doing at pushing…   Read more»

]]> 3a2a216015df8b64d38b6c4c791420b4 https://medicaldevicecourses.com/activity/p/20403/ Mon, 21 Sep 2020 01:26:24 -0400 Horwich. A, Weissman, J. “Deadly Conformations—Protein Misfolding in Prion Disease” Cell Press. Cell, Vol 89. 499-510. 16 May, 1997. Accessed Online 20 September 2020

]]> e90ae1ecfa9a7fd76b4aecfb56979eb9 https://medicaldevicecourses.com/activity/p/20402/ Mon, 21 Sep 2020 01:24:34 -0400 There are obvious factors that will dictate which biomaterial we choose for out medical device, like biocompatibility, tissue mimicry, low toxicity, and other. However, I think the factor that would have an impact on the smoothness of the project would…   Read more»

]]> 45bb95b37453d7129412449bcc0d3c0d https://medicaldevicecourses.com/activity/p/20399/ Mon, 21 Sep 2020 01:15:40 -0400 Like many of you, I hold my reservations to the type of animal used for testing. I also have a dog and would be indifferent to think about animal testing done on any dog, but the reality is that these…   Read more»

]]> 9fa073d7c1a69ff132852ac54ba20738 https://medicaldevicecourses.com/activity/p/20330/ Wed, 16 Sep 2020 03:17:57 -0400 This is a very interesting and controversial point. I think that the need for COVID-19 alleviating devices justified the need to postpone other pending devices or drugs approvals and patents. This pandemic reached a critical level that hospitals and clinics…   Read more»

]]> d50d9ab3dfb5debb80e282dc9aeec7d2 https://medicaldevicecourses.com/activity/p/20313/ Mon, 14 Sep 2020 02:45:35 -0400 The project outcome is only as strong as the stages it takes to develop it. The final outcome does not weigh over all of the cost, length of time, and development that must be done to complete it. Like mentioned…   Read more»

]]> beb66027f505f3a9e15885a0a6765431 https://medicaldevicecourses.com/activity/p/20311/ Mon, 14 Sep 2020 02:04:17 -0400 Hello All,  This thread is a little bit of a surprise to me. I would have thought that the (RA) regulatory associate would be one of the most essential people in the entire group. It seems logical to have a…   Read more»

]]> e4cbf50811efe7f0bb991efb9aba8007 https://medicaldevicecourses.com/activity/p/20309/ Mon, 14 Sep 2020 01:35:42 -0400 Hello, On one of the lectures Dr. Simon mentions that project management positions are usually not given to entry level engineers. I believe that overall the position entails a lot of moving parts and different departments collaborating together that you…   Read more»

]]> 92669e03ac299fc48b872ee8131e98c7 https://medicaldevicecourses.com/activity/p/20290/ Sun, 13 Sep 2020 20:06:25 -0400 Hello All,  I too work in a laboratory like both of you mentioned above, but I focus on cytogenetics in a pathology lab. My background is in biology and i am pursuing this degree to transition into the biomedical engineering…   Read more»

]]> 17845f74ba9354cead3ec355f10b7e7a https://medicaldevicecourses.com/activity/p/20289/ Sun, 13 Sep 2020 18:08:21 -0400 The “Jack of all trades and master of none” is definitely the best way to describe BME. While I can see the potential in knowing something of every field and having background in many different areas of BME, I will…   Read more»

]]> 3ad4e15d9e0a7742faaf796058099bbf https://medicaldevicecourses.com/activity/p/20238/ Thu, 10 Sep 2020 13:24:38 -0400 0