https://medicaldevicecourses.com/members/patricia/activity/ Activity feed for pi29. Sat, 25 Apr 2026 04:09:50 -0400 https://buddypress.org/?v= en-US 30 hourly 2 5fa40bbb9007bd3ada4c337a549a498f https://medicaldevicecourses.com/activity/p/21053/ Sun, 29 Nov 2020 22:33:22 -0500 I would not start work without a written agreement. A verbal agreement can be misconstrued, and the details forgotten or tweaked along the way (increase in scope). One person can change their mind later and contradict what they originally agreed…   Read more»

]]> abf07c50166e78db61e57539f21b0618 https://medicaldevicecourses.com/activity/p/21052/ Sun, 29 Nov 2020 22:27:01 -0500 I do believe these restrictions are necessary. As many have mentioned before, greed can become a problem and the money can maybe cloud the judgements of some. One thing that comes to mind is an article I read several years…   Read more»

]]> f7726ede09194d0fedbde1b2b561063f https://medicaldevicecourses.com/activity/p/21051/ Sun, 29 Nov 2020 21:59:14 -0500 The company I work for works mainly with HCT/Ps which are regulated less stringently than medical devices by the FDA. For one particular project, the product was a biologic however this company had not navigated through this regulatory pathway before….   Read more»

]]> cdd8426c496b42d68f0098ad537fad50 https://medicaldevicecourses.com/activity/p/21021/ Mon, 23 Nov 2020 05:03:06 -0500 The company I work for currently has a functional structure but we are starting to transition into a matrix structure. We are at the beginnings of this so I haven’t experienced much of a change so far however I am…   Read more»

]]> c3e2159265dbc69ea5368dd7db81b13a https://medicaldevicecourses.com/activity/p/21019/ Mon, 23 Nov 2020 04:52:49 -0500 The way I have seen the company I work for put together a project team is by taking into consideration area of expertise and workload. At the company I work for we are divided into different segments depending on product…   Read more»

]]> 0ac2b41a30775874f05050ef74714488 https://medicaldevicecourses.com/activity/p/21015/ Mon, 23 Nov 2020 04:46:21 -0500 I had not considered myself to do more management roles since I prefer the technical side of things. However I have been exploring the idea lately. To echo what everyone else has said, as a person with little to no…   Read more»

]]> 2289b3b676f68aa70b96f9d596895ad0 https://medicaldevicecourses.com/activity/p/20897/ Sat, 14 Nov 2020 20:09:40 -0500 Hi Everyone,  FMEA documents can be very lengthy and tedious to review. Often times I find it difficult to start. I attended an FMEA training last year where they recommended to gather all the key members of the team, the…   Read more»

]]> f6bc580a75ff2e92d96decac8319fd3a https://medicaldevicecourses.com/activity/p/20896/ Sat, 14 Nov 2020 19:32:14 -0500 A risk benefit analysis can be done to determine whether the risk outweighs the overall benefit to the patient. As mentioned above, vaccines are a good example since the overall immunity you get has more benefit where the alternative is…   Read more»

]]> 5b3610fe146cac63c5def81e6b98953a https://medicaldevicecourses.com/activity/p/20881/ Wed, 11 Nov 2020 03:02:28 -0500 In my experience we tend to use FMEAs more. We use them as described by Dr. Simon in his lectures and also for determining risk in non-conformances. When we have process deviations we use the FMEA format to list all…   Read more»

]]> cd1971e5d64f9d0e3d088cbd37cd4f6b https://medicaldevicecourses.com/activity/p/20851/ Mon, 09 Nov 2020 02:06:26 -0500 I have also used reliability and confidence to determine sample sizes for testing during validations. I have also used AQL (acceptable quality limits) sampling when doing additional testing to mitigate risks observed with processed non conforming products. We also use…   Read more»

]]> ddd0e419e152d695d66cad6e45943e63 https://medicaldevicecourses.com/activity/p/20844/ Mon, 09 Nov 2020 01:08:15 -0500 An example I have encountered on when validation wouldn’t be required is related to product packaging. At the company I work for we have a validated product A with packaging A. We are working on bringing to market product B…   Read more»

]]> afdf330b03047d8e1f060918fccfef67 https://medicaldevicecourses.com/activity/p/20842/ Mon, 09 Nov 2020 00:48:46 -0500 The change control process should identify everything that the change would impact and create an action plan for how to address the results of the changes. An example of an inadequately planned change is, at my company the flipping of…   Read more»

]]> 523dfdf74bf2400c85e3385874626b64 https://medicaldevicecourses.com/activity/p/20772/ Sun, 01 Nov 2020 20:01:34 -0500 I agree with everyone that keeping meeting minutes is super important. It gives you something to reference in the event that you missed something in your personal notes. I know personally looking back at meeting minutes has been helpful in…   Read more»

]]> 92267f86f856da6de1ae32ea9c05eece https://medicaldevicecourses.com/activity/p/20745/ Fri, 30 Oct 2020 13:23:10 -0400 There are different types of validations that can be performed. I have done packaging stability validations, product stability validations, and shipping configuration validations. Below is a brief description of each. I would be interested to know what other validation types…   Read more»

]]> 3af6c58210965b1233c1d54cf628db2e https://medicaldevicecourses.com/activity/p/20744/ Fri, 30 Oct 2020 04:23:35 -0400 From my experience in industry I would echo everyone who has said that you need to consider delays/setbacks and build that into your timeline. I worked on one particular project that had a very ambitious timeline with little to no…   Read more»

]]> 4c5773fa9548a756aadaa7002bb4625d https://medicaldevicecourses.com/activity/p/20727/ Mon, 26 Oct 2020 03:45:28 -0400 I actually didn’t know this law existed! At a glance it sounds like a good thing. For terminally ill patients this could provide a sliver of hope or a chance for them to contribute to science. Given my limited knowledge…   Read more»

]]> bd6f265d9d2565eff6a4646d68f260b6 https://medicaldevicecourses.com/activity/p/20726/ Mon, 26 Oct 2020 03:33:35 -0400 The original post mentions that “Placebo is better than no treatment” however I believe placebo means no treatment is actually given. For example a placebo for an injectable drug could be a saline injection.  I do see the ethical dilemmas…   Read more»

]]> 5110812581d4b8560a66b4d1ca3c54a3 https://medicaldevicecourses.com/activity/p/20725/ Mon, 26 Oct 2020 03:15:08 -0400 My opinion is that humans have a right to decide what they want to do with their body including whatever is removed during a surgery. Some people do not want their tissues/specimen to be part of research and  to me…   Read more»

]]> 5af7319093298bf7a53e6db3046b0c10 https://medicaldevicecourses.com/activity/p/20656/ Sun, 18 Oct 2020 21:23:37 -0400 One example in particular came to mind when I thought about manipulation in sales. Apple recently launched their new iPhone 12 phones and are not including the wall charger and earbuds which they say is a more environmentally friendly approach….   Read more»

]]> 32b07215ad30c4ba2d6bef61df25706e https://medicaldevicecourses.com/activity/p/20653/ Sun, 18 Oct 2020 20:27:59 -0400 Colors can influence your feelings and actions. If you see red you might think danger or stop, green could be positive and encouraging. I found a chart of different colors, words associated with them, and what companies use these colors:…   Read more»

]]> 23e5012b628860391c85daee501c7cf5 https://medicaldevicecourses.com/activity/p/20652/ Sun, 18 Oct 2020 20:06:19 -0400 I found this video very entertaining! I haven’t had a similar experience with external customers but have witnessed a milder version of this within a project team. On a recent project, we faced a lot of challenges and setbacks due…   Read more»

]]> a2bd2469c27af0e8d780b93a139fa8f1 https://medicaldevicecourses.com/activity/p/20608/ Mon, 12 Oct 2020 03:59:46 -0400 In the medical device/pharmaceutical industry most are for profit companies, however there are some companies such as tissue banks that are non for profit. Do any of you work for a non for profit company and how do they handle…   Read more»

]]> f803ffc9be6b185b7d86c12f72669d84 https://medicaldevicecourses.com/activity/p/20606/ Mon, 12 Oct 2020 03:57:23 -0400 I would choose a sole proprietorship unless I knew my partner very well. Even then I feel like you never really know a person until money is involved. In a sole proprietorship I would be able to make all the…   Read more»

]]> 973e7df87375599d7fcab755f22c5238 https://medicaldevicecourses.com/activity/p/20603/ Mon, 12 Oct 2020 03:08:16 -0400 As a person fresh out of college with little experience, yes I would have accepted the role if there were no other opportunities out there for me. It is very difficult to get a job offer and though absolutely not…   Read more»

]]> 480d5de53e39d99b2a2f9857a3eca5a9 https://medicaldevicecourses.com/activity/p/20552/ Mon, 05 Oct 2020 03:31:52 -0400 As a quality engineer the most crucial qualities have been organization and the ability to find information. Organization has come in very handy when running validations. There are many moving parts, many things to keep track off and document (if…   Read more»

]]> d77d6e0ca23463fa7a8cdb13f2213651 https://medicaldevicecourses.com/activity/p/20551/ Mon, 05 Oct 2020 03:26:07 -0400 I have not encountered ethical issues during my experience as a quality engineer, however following ethics is very important. It’s crucial to be honest and responsible when working with data and designing studies. Patient safety should always be priority when…   Read more»

]]> 49616081666cb117070e7874094b0bc6 https://medicaldevicecourses.com/activity/p/20503/ Fri, 02 Oct 2020 02:43:17 -0400 In my experience in quality engineering, we get mixed responses, mostly positive. Usually everyone works well and we are taken into all projects to make sure we are doing things correctly. However, I have received hesitation/disapproval (maybe?) when suggesting to…   Read more»

]]> 7b48b609f5047a5f9dfc3fe6e433edf3 https://medicaldevicecourses.com/activity/p/20472/ Mon, 28 Sep 2020 02:49:32 -0400 I have not worked on a regulatory project, however I have worked with regulatory. I figured I would share to give a perspective of some things Regulatory people do. I work often on non conformances within the company. These are…   Read more»

]]> 7080894fa7c1ee677689243d1032eb0b https://medicaldevicecourses.com/activity/p/20467/ Mon, 28 Sep 2020 01:30:11 -0400 Recalls are made because a risk to patient safety was identified whether it be for the entire product line or with a certain lot of the product. I can try to give an example of when I think there would…   Read more»

]]> f7ffce5cc491273ab5ca78e1636402b9 https://medicaldevicecourses.com/activity/p/20466/ Mon, 28 Sep 2020 01:12:16 -0400 I would say I have had the opportunity to work with people from very different cultural backgrounds, not just in my current job but in college, and throughout my early education. I personally think it brings value to the team…   Read more»

]]> 09df667177a06f8ef2cd21454ab9055e https://medicaldevicecourses.com/activity/p/20408/ Mon, 21 Sep 2020 03:43:22 -0400 I do think it is unethical however I understand the need for it. Animal testing is critical for advancing medicines and bringing them to patients. Unfortunately, until we find an ethical alternative I don’t see this changing any time soon….   Read more»

]]> dce824235166168b0756a4e4fbf875ec https://medicaldevicecourses.com/activity/p/20407/ Mon, 21 Sep 2020 03:23:49 -0400 I think both are equally important. I prefer to take part in research that would help people now or in the near future (10 years down the line). I wouldn’t like to take part in research that won’t reach patients…   Read more»

]]> f9521a8ee5ce71f1b6cee29153c6eafb https://medicaldevicecourses.com/activity/p/20400/ Mon, 21 Sep 2020 01:17:32 -0400 What I personally find attractive in working for academia is the creative freedom and the opportunity to work in what you are passionate about. You are able to decide the topics that interest you and create a project out of…   Read more»

]]> f01fe085706bf596efb598f97f19b9cb https://medicaldevicecourses.com/activity/p/20288/ Sun, 13 Sep 2020 14:17:19 -0400 Missing a milestone can be due to poor planning or you find an error that needs to be fixed because it could pose a threat to the end user. I work in a tissue bank where we receive donated human…   Read more»

]]> 2866af820589033b6a541b543a181bc8 https://medicaldevicecourses.com/activity/p/20287/ Sun, 13 Sep 2020 13:53:33 -0400 I have experienced great project managers and okay ones. The great ones have very good soft skills. They can communicate effectively, set realistic deadlines, be flexible when needed, approach problems with an open mind, have a solid technical background to…   Read more»

]]> 1298dbe42db4245910c1d4a684e7c941 https://medicaldevicecourses.com/activity/p/20286/ Sun, 13 Sep 2020 13:36:14 -0400 The project I am currently working on actually had 2 project managers for a couple of months. The reason was this: project manager A was the main one on the project however she went on maternity leave. This is when…   Read more»

]]> a367f136bdb6deb9c33de13b960227f5 https://medicaldevicecourses.com/activity/p/20222/ Sun, 06 Sep 2020 03:36:55 -0400 I graduated about a year ago now and the main things that stuck out to me that I wish I knew are the following: 1. Out of all the math courses you will take as an engineer statistics is the…   Read more»

]]> d2d72d415e628ae391185aa55036a7cb https://medicaldevicecourses.com/activity/p/20221/ Sun, 06 Sep 2020 03:17:11 -0400 The exposure I had in academia was during an undergraduate research fellowship (about 2.5 years) in which I interacted with a lot of post-docs and phd students. I am now working in industry. The main thing that stands out to…   Read more»

]]> 68523a5436a052ee99d0bcd12bd00d31 https://medicaldevicecourses.com/activity/p/20219/ Sun, 06 Sep 2020 02:57:45 -0400 I agree that as a biomedical engineering major who currently works in the tissue bank industry, most of the knowledge and skills that I have, I have learned on the job. As a bme student like you mentioned we learn…   Read more»

]]> 88b6b7ce8144affa758b448bc0cd3af5 https://medicaldevicecourses.com/activity/p/18370/ Wed, 15 May 2019 21:47:43 -0400 I think having challenging work and receiving praise for what you have accomplished can be related but they aren’t necessarily. You could receive praise fore doing menial work just like you could for doing challenging work. If you feel you…   Read more»

]]> 15fb1663d3baad1e2ca8597857cc8868 https://medicaldevicecourses.com/activity/p/18369/ Wed, 15 May 2019 21:47:42 -0400 I think it’s better to outsource if you aren’t as qualified to run a clinical trial. If you lack the resources in man power and knowledge you are better off hiring a CRO to do the clinical trial for you….   Read more»

]]> 9fdb81cc2855b2d4020bd987e7249722 https://medicaldevicecourses.com/activity/p/18368/ Wed, 15 May 2019 21:47:42 -0400 To have a good relation with vendors I think you need to be able to communicate with them appropriately and this includes language barrier. As was seen in this simulation, the language barrier really complicated everything. Additionally to make communication…   Read more»

]]> 9a33e88dff33ccb625c544bdbd2ba33f https://medicaldevicecourses.com/activity/p/18297/ Wed, 15 May 2019 21:47:04 -0400 I strive to do my best and stand out, however I love learning new things and feeling stimulated. When things become routine and I feel like i’m just pushing papers without little input as to what can go into it…   Read more»

]]> 4ccd43510b0c8bfab9957d8c586239f4 https://medicaldevicecourses.com/activity/p/18296/ Wed, 15 May 2019 21:47:03 -0400 I think that sharing ideas with others in your group definitely helps. Everyone has a unique way of seeing things and can shine light on certain details you might have missed. During the first simulation I had a bit of…   Read more»

]]> 62480aff41bf86515fd2e9794b86a66b https://medicaldevicecourses.com/activity/p/18295/ Wed, 15 May 2019 21:47:03 -0400 I would choose a project management position but only after working as an engineer for a couple of years. I think having that technical background and actually knowing the process and work the engineers go throughout validate and create processes…   Read more»

]]> a1bd2cdcef45f9793dab796b340daed5 https://medicaldevicecourses.com/activity/p/18294/ Wed, 15 May 2019 21:47:02 -0400 I found that a lot of what was mentioned in this class helped me fill in the gaps in my industry knowledge. I have been working as a quality engineering intern for a couple months now and though I have…   Read more»

]]> 61545c93094baf25ca66c9bf7d03ca5a https://medicaldevicecourses.com/activity/p/18161/ Wed, 15 May 2019 21:45:54 -0400 QA or Quality Assurance makes sure that the project is meeting all industry regulations. For example if you want to set new storage conditions for one of your devices, you consult the quality assurance specialist to make sure that this…   Read more»

]]> 76b3592ef6335ed6abe44a84355353a9 https://medicaldevicecourses.com/activity/p/18158/ Wed, 15 May 2019 21:45:52 -0400 In your example I think that if possible those critical team members should have notified of their availability for the dates needed. The project manager should have asked if she/he did not if there were any vacation days coming up…   Read more»

]]> cfda1367fec443de1b73a8c8cc5d3307 https://medicaldevicecourses.com/activity/p/18155/ Wed, 15 May 2019 21:45:51 -0400 I agree with these factors for the following reasons: It’s important for everyone on the team to be on the same page and therefor agree with the project goals. If a team member doesn’t agree or has concerns it’s important…   Read more»

]]> 205f81717bcea2731660bbe1f5a91a3c https://medicaldevicecourses.com/activity/p/18067/ Wed, 15 May 2019 21:45:07 -0400 The planned value and actual cost serve as points of comparison throughout the project to monitor what the current value of the project is to what the planned value is. And the actual cost helps determine how much it will…   Read more»

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