https://medicaldevicecourses.com/members/jr377/activity/ Activity feed for jr377. Fri, 24 Apr 2026 23:46:26 -0400 https://buddypress.org/?v= en-US 30 hourly 2 4d0180219010901a4c6154b7bbeb6a0e https://medicaldevicecourses.com/activity/p/18335/ Wed, 15 May 2019 21:47:24 -0400 One thing to keep in mind is that you’re not the only customer of the vendor. You might have a specific representative from that vendor as your go-to, but the vendor may have other orders for products, maintenance of machines,…   Read more»

]]> 3814e39c28696792d6ac8a319aaaf62c https://medicaldevicecourses.com/activity/p/18334/ Wed, 15 May 2019 21:47:24 -0400 I believe that the disconnect was a larger issue in the past. I feel that companies (at least in my limited experience) actually are actively removing that disconnect. It’s a big issue to have. Rewarding teamwork and speaking your (helpful)…   Read more»

]]> ad9ef34e15ccb38521d2768f4ef32552 https://medicaldevicecourses.com/activity/p/18333/ Wed, 15 May 2019 21:47:23 -0400 These are all fairly obvious reasons for leaving a job to move to a different one. I’m actually curious as to the other, maybe less common, reasons why people leave. What about those who need to leave to take care…   Read more»

]]> 9611a5a5b76f96d3010a387db58296be https://medicaldevicecourses.com/activity/p/18261/ Wed, 15 May 2019 21:46:46 -0400 I will add another fact, that american workers get less vacation than other workers in other countries. One aspect of why they work more that I haven’t seen above is that they want to make a good impression. People who…   Read more»

]]> ee63ed856045c9b874619f3c8ac84340 https://medicaldevicecourses.com/activity/p/18260/ Wed, 15 May 2019 21:46:46 -0400 I will reinforce an aspect of motivation (as many of you have said above). The main thing a manager needs is to ensure that their subordinates feel like they have a personal stake in the project’s success. That is the…   Read more»

]]> c276f4044906380630da3874c98c8a69 https://medicaldevicecourses.com/activity/p/18259/ Wed, 15 May 2019 21:46:45 -0400 This is a very interesting study and I wish i could find more about it. When was it taken, how many people, what age group, etc? All of these are factors on the percentages of each answer. I did expect…   Read more»

]]> 36c809d3a2cd560de2129ceb5a5b0ab0 https://medicaldevicecourses.com/activity/p/18201/ Wed, 15 May 2019 21:46:13 -0400 I’ll add to what’s been said above. People who work QA usually work with the people who are writing SOPs, change controls, etc. They’re in the office making sure that all of the paper work and paper trail are correct…   Read more»

]]> ea27a3b332a4d721eebd999d95488c89 https://medicaldevicecourses.com/activity/p/18200/ Wed, 15 May 2019 21:46:13 -0400 Reactive management is sometimes unavoidable. Proper planning is crucial, but there will always be issues that arise that either you couldn’t or didn’t foresee. Things happen. Having a robust system to ensure that any problems are solved quickly is vital….   Read more»

]]> e69d1df9a243a003f8cb2952b120c0d9 https://medicaldevicecourses.com/activity/p/18199/ Wed, 15 May 2019 21:46:13 -0400 I doubt that changing positions mid-project is something that happens often. If it does, I would still think that they would continue their role in the project or at the very least assist the person who is taking over their…   Read more»

]]> cfa513660982758b5ecb7d2a812f8cf4 https://medicaldevicecourses.com/activity/p/18132/ Wed, 15 May 2019 21:45:40 -0400 I’d disagree jb678. It really depends on how much it would cost. Being behind schedule costs money, just as being over budget. Being behind schedule might cost just as much if not more. As said before we would really need…   Read more»

]]> 8c9388676a3ff334db29f27c9a89fae3 https://medicaldevicecourses.com/activity/p/18129/ Wed, 15 May 2019 21:45:38 -0400 Well there’s a few factors that affect this. What level employee are you? Managers may have a harder time taking off if they cannot get the appropriate person to hold the reins while they’re away. A lower “grunt” may have…   Read more»

]]> 83198f45d6211d824ddaec5693c63bd6 https://medicaldevicecourses.com/activity/p/18128/ Wed, 15 May 2019 21:45:38 -0400 I agree with jb678. I feel that it’s easier to control creep in some projects rather than others. For example, mirroring a manufacturing facility is easier than building one from scratch. Yet, there are always going to be issues that…   Read more»

]]> 700ac7bb837a6dadb96f45287cd8b0c3 https://medicaldevicecourses.com/activity/p/18048/ Wed, 15 May 2019 21:44:57 -0400 I may not be as experienced as other people in this class so I can only speak as to what I’ve seen. I’ve never seen a phase skipped over to start the next before the completion of the previous. I…   Read more»

]]> 7127374df88a0d086b9ca34d94f198dd https://medicaldevicecourses.com/activity/p/18046/ Wed, 15 May 2019 21:44:56 -0400 I agree with most of what you’ve said, but it seems you haven’t addressed setbacks, major or minor. Weekly planning meetings, from my experience, deals with changes to the schedule and accommodates any issues that may come up. There may…   Read more»

]]> 0c05c152433b5107e043433ada2f6ad6 https://medicaldevicecourses.com/activity/p/17964/ Wed, 15 May 2019 21:44:13 -0400 I think you need to have both. Risk management should be taken into consideration the entire process, but the final approval should be done by different people in risk management. This makes me think of quality teams. They are involved…   Read more»

]]> 04f87b12e7967aa65dae6271451d10ec https://medicaldevicecourses.com/activity/p/17963/ Wed, 15 May 2019 21:44:12 -0400 I don’t know what company you’re talking about and I’m not sure if I’m looking in the right place (all I can find is avengers stuff). That’s good that they’re checking each step. There’s a lot of aspects of cGMP…   Read more»

]]> b114dba97921cfbe0fd78d732084e258 https://medicaldevicecourses.com/activity/p/17962/ Wed, 15 May 2019 21:44:12 -0400 Well judging from what I’ve seen a few things could happen. The first is that you notify them and try and fix the problem. If they’re slow to respond then you would start looking into other vendors. I assume that…   Read more»

]]> 913031f1fd952d4e9683cfd5cb61c75c https://medicaldevicecourses.com/activity/p/17911/ Wed, 15 May 2019 21:43:47 -0400 I agree with what you you guys have said, I just want to add that people with experience on projects are a great asset when determining issues. They may have seen certain things that came up and negatively affected their…   Read more»

]]> d3ef007ce13ffde91ec4f37853e416d6 https://medicaldevicecourses.com/activity/p/17910/ Wed, 15 May 2019 21:43:46 -0400 I currently work in a pharmaceutical company, and we are in the process of getting all of our equipment and process verified and validated. We need to ensure sterility, appropriate amounts of product, etc. I am somewhat new to the…   Read more»

]]> 35e26f15813d7e31279efa33e191549f https://medicaldevicecourses.com/activity/p/17909/ Wed, 15 May 2019 21:43:46 -0400 I’m not sure there is one. Every stage has it’s role to play. Maybe you could say that starting off strong is important, but the others can’t fail or else the entire project is a failure. Did you have one…   Read more»

]]> c35be50cac65849e2ae7de87eebe90d8 https://medicaldevicecourses.com/activity/p/17848/ Wed, 15 May 2019 21:43:13 -0400 Manolo you didn’t really address my point of even if there were no regulations, the cGMP violations would eventually cause some problem. Probably people getting sicker/dying. That would cause lawsuits and the loss of reputation I talked about above. That…   Read more»

]]> 51f21f549a16b863c9cfe49413738d8b https://medicaldevicecourses.com/activity/p/17847/ Wed, 15 May 2019 21:43:13 -0400 Anthony, I’m not sure that employee and contract payments are the issue in that. Full time employees get salary, so they usually would be working on another project/aspect if they finish early. Contractors get paid hourly (for the most part)…   Read more»

]]> 9720d695372085d659baf23a8ef69a8c https://medicaldevicecourses.com/activity/p/17846/ Wed, 15 May 2019 21:43:12 -0400 From what I’ve seen there’s a few things that happen. When making a timeline, if the task seems similar to previous tasks, they will use the previous task’s timeline as an indicator of how long it will take. There is…   Read more»

]]> da60be897163f3717623ac8efeaadec9 https://medicaldevicecourses.com/activity/p/17762/ Wed, 15 May 2019 21:42:26 -0400 I’m not why you have a question about this, it seems pretty straightforward to me, even if you look at this through a purely financial lens as opposed to a morality lens. I assume that you believe that it’s the…   Read more»

]]> e085993047eae87e3f4c9b3f26280bff https://medicaldevicecourses.com/activity/p/17761/ Wed, 15 May 2019 21:42:26 -0400 Building in delays is a good idea, but one thing no one has talked about is how long that buffer should be. You can’t make it too long or else you may give the impression that the project shouldn’t be…   Read more»

]]> f37e19bfb49bf2f4482a3195897e2e3a https://medicaldevicecourses.com/activity/p/17760/ Wed, 15 May 2019 21:42:25 -0400 I’m not 100 percent sure on what your point is but I’ll try to answer to the best of my ability. The only situation I can see when that might be an issue is when a project leader gets promoted…   Read more»

]]> 7b35f2653c778d985abc1ec9a5b6f5e3 https://medicaldevicecourses.com/activity/p/17673/ Wed, 15 May 2019 21:41:38 -0400 If you look at every person that works their way up in the company, there’s one thing they always have: strong interpersonal skills (or are at least improving those skills constantly). There’s a saying at Merck: “When you think of…   Read more»

]]> b5e08fbec6b86dd4b921b9a86a134484 https://medicaldevicecourses.com/activity/p/17672/ Wed, 15 May 2019 21:41:38 -0400 ajm73 I agree with your sentiment that some countries will not recognize it. They will definitely have some of their own specified regulations. For example, most regulatory agencies as I said before have de facto standards because it’s a basic…   Read more»

]]> 7ead288c4c96b3cb2524d511f3212781 https://medicaldevicecourses.com/activity/p/17671/ Wed, 15 May 2019 21:41:37 -0400 This is an interesting question and I haven’t heard of such a thing before. The short answer is: they have to worry about it. The FDA is a national regulatory agency, but states have the right to pass their own…   Read more»

]]> 6f94e834c18c34830568b067b7fe2572 https://medicaldevicecourses.com/activity/p/17628/ Wed, 15 May 2019 21:41:15 -0400 I mostly agree with what what said above. I believe there is a hierarchy of importance. First, the device needs to be within tolerance of it’s designed use. You can’t have an implant that is too big or small from…   Read more»

]]> 130212d9d0eda8ee4f98c353ccafb224 https://medicaldevicecourses.com/activity/p/17627/ Wed, 15 May 2019 21:41:15 -0400 For most companies in the BME industry, they operate globally. This means that they have to adhere to all of those nation’s regulatory agencies. There are agencies such as EMEA, CFDA, ANVISA, etc. that come to the US to ensure…   Read more»

]]> 8d526d69659926bac66a597ca49f9ac0 https://medicaldevicecourses.com/activity/p/17626/ Wed, 15 May 2019 21:41:14 -0400 I feel like the point that verification/validation will not always pass needs to be brought up more. Companies need to keep in mind that the verification and validation steps will not pass, so that if they fail the timeline is…   Read more»

]]> 58ca975bf7fb0437b32a5397402ba188 https://medicaldevicecourses.com/activity/p/17526/ Wed, 15 May 2019 21:40:16 -0400 Most companies invest in potential projects until there are serious signs of non-viability. They spend millions on R&D for that purpose. Every project has the potential to become the next breakthrough in the field. As said above, if they can’t…   Read more»

]]> 7a872d2e33fa274ab584bfc1b486b0aa https://medicaldevicecourses.com/activity/p/17525/ Wed, 15 May 2019 21:40:15 -0400 I agree with both zbw2 and alexandra. The FDA establishes minimum requirements in terms of safety and testing. Many companies choose to hold themselves to a higher standard. If something goes wrong, they can lose millions in terms of recall…   Read more»

]]> 6934c533fc12101d13de12cd4e273148 https://medicaldevicecourses.com/activity/p/17524/ Wed, 15 May 2019 21:40:15 -0400 Well this is an interesting point. Acupuncture has been done for centuries, so safety doesn’t seem to be a concern. However, the needles have been known if migrate if left in the body. Whether or not it is effective is…   Read more»

]]> 6626c7d4fcc5c59a513136a0156b92eb https://medicaldevicecourses.com/activity/p/17463/ Wed, 15 May 2019 21:39:44 -0400 May 2018 saw the signing of the “right to try” bill into federal law. It allows terminally ill patients to try experimental drugs, biologics, and devices that have completed phase I testing but hasn’t been FDA approved. Whether or not…   Read more»

]]> e4844f063d3c5084165df2dd709f04f5 https://medicaldevicecourses.com/activity/p/17462/ Wed, 15 May 2019 21:39:43 -0400 A missing or erraneous label means that the product can not and should not be used. FDA regulation is strict for a reason. If anything is wrong with the product people can become very sick or die. The amount of…   Read more»

]]> dd16732a0e32186741f1a868cb7ebaf4 https://medicaldevicecourses.com/activity/p/17461/ Wed, 15 May 2019 21:39:43 -0400 I’m not a fan of giving either percentages of importance. It may differ from situation to situation. Of course, both are important. You need a have a good handle on both in order to be effective. Knowing what needs doing…   Read more»

]]> 7852de94005009a6d1ba14fdebee667e https://medicaldevicecourses.com/activity/p/17333/ Wed, 15 May 2019 21:38:37 -0400 It is a tricky subject. On one hand kickbacks are an obviously bad thing. However small gifts are good ways to start/improve relationships. I think that $100 is a good cap, and limiting it to the physician only seems to…   Read more»

]]> 6eff5bd96be490aeb68d71030b7fb2a3 https://medicaldevicecourses.com/activity/p/17331/ Wed, 15 May 2019 21:38:36 -0400 This course has been really useful, and I know I’ll be looking back at these forums and documents in the future. The information is well rounded. I wish we could have gone a little more in-depth but with the amount…   Read more»

]]> 4ec7f6be334ea81b4ecf463cf2a75b26 https://medicaldevicecourses.com/activity/p/17330/ Wed, 15 May 2019 21:38:36 -0400 I noticed that no one talked about a recorded phone call/video call. I’m not sure which it would count under. Technically its not written, pushing my assumption of it being an verbal agreement. However, it is easily proven, especially in…   Read more»

]]> a2d573ea6a6f001e906b52c9b4ad06a7 https://medicaldevicecourses.com/activity/p/17265/ Wed, 15 May 2019 21:38:04 -0400 As stated you don’t usually get to choose. That being said, I think you need to lean on the knowledge vs compatibility side. For the sake of giving percentages, let’s say 70/30. You can people who have great relationships but…   Read more»

]]> 1ba943315ff1767104ebc5c13f740922 https://medicaldevicecourses.com/activity/p/17264/ Wed, 15 May 2019 21:38:03 -0400 I don’t think that it matters if you want to be upper management if you’re bad at middle management. I may be wrong, but I’m pretty sure that upper management gets promoted from middle management. You have to be good…   Read more»

]]> e9c6f2a6a4def3eb5611ba82e7ee22d4 https://medicaldevicecourses.com/activity/p/17263/ Wed, 15 May 2019 21:38:03 -0400 Personally I believe I would rather be in a functional organization. I like clear cut positions and knowing how to advance. Interdepartmental coordination shouldn’t be as much of a problem compared to the other types. I wouldn’t want to be…   Read more»

]]> 832a4405d05f9bdc2f8693990bf73cab https://medicaldevicecourses.com/activity/p/17142/ Wed, 15 May 2019 21:37:00 -0400 I’m going to use a non-BME example to help clarify my thoughts. Whenever you get a coffee, the cup will usually have a label that warns that it is in fact, hot. Seems silly right? Well it’s a result of…   Read more»

]]> 60a3d36d93b433519685e673bb33f6e8 https://medicaldevicecourses.com/activity/p/17140/ Wed, 15 May 2019 21:36:59 -0400 From best to worst option for each risk level- High risk: Avoidance, Mitigation, Transference, Acceptance Medium risk: Mitigation, Transference, Avoidance, Acceptance Low risk: Acceptance, Transference, Mitigation, Avoidance High risks need to be dealt with or else you may have major…   Read more»

]]> 264e8050aca42e8b8100b411de82ac30 https://medicaldevicecourses.com/activity/p/17139/ Wed, 15 May 2019 21:36:59 -0400 I believe that “There is no such thing as a free lunch” is a really applicable quote for this situation. As stated previously stated, there are costs to hiring people to create and maintain this standard. All of the work…   Read more»

]]> 91eaed8bed7d3337ab742171bda6db01 https://medicaldevicecourses.com/activity/p/17069/ Wed, 15 May 2019 21:36:24 -0400 I haven’t actually had the experience to comment with a story of my own, but I do have a few questions that tie into this subject. How often do failed verification tests occur? It seems like verification failures occur more…   Read more»

]]> 339413fa3aed81b42cda0e73c7ab53fa https://medicaldevicecourses.com/activity/p/17068/ Wed, 15 May 2019 21:36:23 -0400 sin3, I think you switched verification and validation a little in your mind. Verification determines, like you said, every input has an output. Those inputs would come from the DID. Validation however, is what is used to determine whether or…   Read more»

]]> 484ff5ea1d3b42985b800c85f3653bf1 https://medicaldevicecourses.com/activity/p/17067/ Wed, 15 May 2019 21:36:23 -0400 I haven’t done statistical tests in industry but I can speak to academic tests I have done. In addition to paired t-tests and one way ANOVAs, mixed ANOVAs and repeated measures ANOVAs are good tests to determine significance between factors….   Read more»

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