https://medicaldevicecourses.com/members/williamzembricki/activity/ Activity feed for williamzembricki. Fri, 24 Apr 2026 17:20:38 -0400 https://buddypress.org/?v= en-US 30 hourly 2 2d91fc0234976d7d75d53274ec34093d https://medicaldevicecourses.com/activity/p/16033/ Wed, 15 May 2019 19:16:25 -0400 Yeah I actually believe that it is almost impossible for a project to focus on just one priority at a time. A project has so many moving parts that focusing one priority would severely slow down the company. A project…   Read more»

]]> d9222fa56ff71d7982c8e55ad9c868e0 https://medicaldevicecourses.com/activity/p/16022/ Wed, 15 May 2019 19:16:14 -0400 When dealing with vendors communication is a large part of what your relationship will be in the future. The fact that a company that supplying us did not speak english is a major concern. If you are not able to…   Read more»

]]> f2a10e3c1e74647b43a834d3492f14fa https://medicaldevicecourses.com/activity/p/16013/ Wed, 15 May 2019 19:16:09 -0400 I feel like this class has been one of the more realistic courses I have taken in college. The same way i learned a lot about medical devices in Dr. Simon’s first course, this class allowed me to bridge the…   Read more»

]]> 4dbc88dc94d84313eb13111868c47840 https://medicaldevicecourses.com/activity/p/15949/ Wed, 15 May 2019 19:15:32 -0400 Personally I have worked for very unmotivated project managers and it can be the most depressing thing to deal with. It does not mean anyone has to spend a lot of money or do anything to amazing. Simply recognizing when…   Read more»

]]> 26f25f9bf4f16612f7a867a142f41b1e https://medicaldevicecourses.com/activity/p/15947/ Wed, 15 May 2019 19:15:31 -0400 I believe it is easier to teach skills then it is to teach motivation. An employee that wants to learn and get better can accomplish a lot more in the long run. An unmotivated employee with a decent level of…   Read more»

]]> 54a16ea4b6e006fa3ea77a5c08a88d44 https://medicaldevicecourses.com/activity/p/15945/ Wed, 15 May 2019 19:15:30 -0400 Company size greatly affects the project that the manager is handling. it could change budget, team member size, and in some cases the quality of the workers that the manager has. It is important for the manager to be able…   Read more»

]]> d6e7c374b8a21db0c20275d58ded122d https://medicaldevicecourses.com/activity/p/15814/ Wed, 15 May 2019 19:14:08 -0400 A project without a plan is a project that is planned to fail. while other documents such as the project management plan might touch on topics that are discussed in the WBS, it will not fully accomplish what the WBS…   Read more»

]]> 46fbbc796254d3efd10914972c0875e3 https://medicaldevicecourses.com/activity/p/15812/ Wed, 15 May 2019 19:14:07 -0400 A problem is much easier to handle if it can be avoided. While this sounds redundant and obvious it is often over looked. The work to fix a problem can lead to much larger issues than the one problem being…   Read more»

]]> 9c2068b5992d7d66c5c24934f46967a2 https://medicaldevicecourses.com/activity/p/15811/ Wed, 15 May 2019 19:14:07 -0400 We saw this week the difficulty in having a very specific DSD. Once the product component was considered a critical component it left us scrambling to find another replacement that would exactly meet the criteria. When design the specifications it…   Read more»

]]> f142a2dc0b2b4d1f99fab6493089cb75 https://medicaldevicecourses.com/activity/p/15535/ Wed, 15 May 2019 19:07:22 -0400 As mentioned before it is clearly necessary for more information to be given, but off the concept of the question it would matter more on the company. Larger companies would most likely be more concerned about the schedule variance as…   Read more»

]]> 5760b240dc37389d63c9d54a036bcab2 https://medicaldevicecourses.com/activity/p/15533/ Wed, 15 May 2019 19:07:21 -0400 When handling changes it must always be considered that no change is as simple as it seems at first. When correcting a simple aspect of a bills of materials it could turn in to a design change and could affect…   Read more»

]]> 7a550a50d72b5e7bba15f4ea044e3662 https://medicaldevicecourses.com/activity/p/15532/ Wed, 15 May 2019 19:07:20 -0400 Metrics is what allows the project to be tracked quantitively vs qualitatively. It takes away bias and personal opinions replacing them with numeric values of accomplishment. These allow companies to begin to understand what needs to be done with a…   Read more»

]]> cf2682fcd555d1c5ac57d56304f48811 https://medicaldevicecourses.com/activity/p/15267/ Wed, 15 May 2019 19:04:37 -0400 Going back on a project is a step backwards but it’s a necessary action to commit. Trying to continue a project without going back and correcting prior mistake will lead to a larger issue further down the road. Also, if…   Read more»

]]> 39e3f89d9977332fb6a7763fda7024c4 https://medicaldevicecourses.com/activity/p/15266/ Wed, 15 May 2019 19:04:36 -0400 This question reminds me of a saying that I believe is very true to the project manager position. It is called the 6Ps, “Proper Planning Prevents Pretty Poor Performance”. If the PM correctly planned the project, it should allow buffer…   Read more»

]]> 841b3b1f932449912d93d5e0aa54731d https://medicaldevicecourses.com/activity/p/15265/ Wed, 15 May 2019 19:04:35 -0400 When dealing with regulations you really can’t fake or placebo the project. If you get away with it, and the product gets released does not mean that you are now good for life. FDA audits can go back as far…   Read more»

]]> 7988b812bab0f89f46ad392d5e52f18e https://medicaldevicecourses.com/activity/p/15125/ Wed, 15 May 2019 19:03:15 -0400 As a risk management chairman in my fraternity I fell very strongly that risk is a big deal no matter what you do. Obviously while working as a fraternity member you are more worried about suspensions and school policy. You…   Read more»

]]> 7f2e8e4acdad3d3e6d8bd848e0e6010e https://medicaldevicecourses.com/activity/p/15118/ Wed, 15 May 2019 19:03:11 -0400 Engineering should be involved when designing the DID. The engineers will be able to give a more educated feasibility rating. Also, even though details are not needed as much in the DID as other aspects of the project it is…   Read more»

]]> aa1343b482e34d35f156edccb7bb91eb https://medicaldevicecourses.com/activity/p/15107/ Wed, 15 May 2019 19:03:06 -0400 When planning and executing any project it is almost normal to fall of schedule I believe. Even when developing a gantt chart there is a critical path and supplementary paths that allow time for slow downs or hiccups. When running…   Read more»

]]> 4ce48e748ee244a3c7d6aa6b872e0c2e https://medicaldevicecourses.com/activity/p/15011/ Wed, 15 May 2019 19:02:09 -0400 I do believe the label is just as much a part of your product as any other aspect. If a label falls off and a product is used incorrectly a company could be liable for leaving the consumer unaware of…   Read more»

]]> 92887f7509aa01292a617612c696bae0 https://medicaldevicecourses.com/activity/p/14993/ Wed, 15 May 2019 19:02:01 -0400 This is a very interesting topic that you have brought up ap962. The knowledge that as934 shared is very knew to me and is a very interesting concept to rad up on. It is good to see that there are…   Read more»

]]> 615167ce257563707785ddcb53a83806 https://medicaldevicecourses.com/activity/p/14988/ Wed, 15 May 2019 19:01:58 -0400 Having previously worked in the medical device industry I have seen the testing they do on products that have already been tested and approved and I can say it is very intensive. To see that products from other companies are…   Read more»

]]> a6b86b847006201ec61af597014c3ebf https://medicaldevicecourses.com/activity/p/14874/ Wed, 15 May 2019 19:00:58 -0400 The risks in a failure during the verification and validation is missing details that will later become a large issue for the engineer or other department that is running the project. Also, not thinking to test an aspect of the…   Read more»

]]> d3017306b8591d3bf89f81e36e767520 https://medicaldevicecourses.com/activity/p/14873/ Wed, 15 May 2019 19:00:57 -0400 Quality will eventually be one of the largest resources a company has is its ability to be confident that the product is able to perform after distribution. The quality testing will also come under high scrutiny from the FDA. After…   Read more»

]]> f6345bb21dcdef26ed1d4af216e70670 https://medicaldevicecourses.com/activity/p/14872/ Wed, 15 May 2019 19:00:57 -0400 I believe that biggest importance with handling a project proposal is to pay strong attention to the details when making the proposal. When details or omitted or forgotten they can become a way larger issue later in the projects development….   Read more»

]]> d97f36b516f2429b981fec12b85022c2 https://medicaldevicecourses.com/activity/p/14711/ Wed, 15 May 2019 18:59:24 -0400 I believe when deciding the primary mode of action, you should see what is the main function and what is the secondary function. The primary function of the digital pill is to deliver the mental illness medication and the sensor…   Read more»

]]> 931dd4b0b468cbfce2da8921b0cd67ab https://medicaldevicecourses.com/activity/p/14708/ Wed, 15 May 2019 18:59:23 -0400 The idea of transplanting a artificial human organ into another human is clearly a Class III procedure. This would definitely require a tremendous amount of testing and would be strictly regulated by the FDA. This testing would not only take…   Read more»

]]> ace0592f279a5062f17981286b73fdb1 https://medicaldevicecourses.com/activity/p/14706/ Wed, 15 May 2019 18:59:22 -0400 The new generation of smart watches does make it a slight bit confusing about whether or not they should be considered a medical device. The device does not monitor blood pressure but it does attempt to monitor the wearers heart…   Read more»

]]> ecccda59e913d2efa5276a9b92f7c043 https://medicaldevicecourses.com/activity/p/14618/ Wed, 15 May 2019 18:58:31 -0400 The most important thing for me in a group aspect is the ability of the team to communicate and work together. A team that is less talented but able to work together well will normally surpass the team that is…   Read more»

]]> f1d9251ad721ba1b33b42348efc3fef8 https://medicaldevicecourses.com/activity/p/14612/ Wed, 15 May 2019 18:58:28 -0400 I believe that it is the schools responsibility to teach the technical aspects of the field. I think it is on the student to learn the outside business and social skills needed to succeed in business. Personally, I believe the…   Read more»

]]> 4b0247791b78822cfe4b76e371175e4d https://medicaldevicecourses.com/activity/p/14603/ Wed, 15 May 2019 18:58:24 -0400 My project management skills are from the corporate standpoint and more from the individual projects I have taken on through my personal life. I have handed school projects well and often taken the leadership role for the projects. In my…   Read more»

]]> d2cf2d128fdd02dbc2ecc5e088bbe461 https://medicaldevicecourses.com/activity/p/14380/ Wed, 15 May 2019 18:55:36 -0400 @Julienneviuya I understand that the spouse does have a good deal of leverage but I have heard that this ca lead to some very uncomfortable situations. As a medical device sales person it is hard to maintain a friendship with…   Read more»

]]> 9be01e474e56f7a7c60d6b15259df1ab https://medicaldevicecourses.com/activity/p/14336/ Wed, 15 May 2019 18:55:14 -0400 I think I would definitely prefer the matrix organization in every position except for the project manager position. I believe that it is difficult to lead a project when the functional managers are constantly pulling on your employees to do…   Read more»

]]> d7712991df7b6616c3ef82b7eb6512fd https://medicaldevicecourses.com/activity/p/14333/ Wed, 15 May 2019 18:55:13 -0400 When it comes to building a project team it is definitely necessary to focus on skills and not personal relationship. I do not believe that it is healthy from work and personal life to overlap too much so to avoid…   Read more»

]]> eec1f4fa4ffd91a135615cb4dab8c1f5 https://medicaldevicecourses.com/activity/p/14331/ Wed, 15 May 2019 18:55:12 -0400 I believe that personally I would be more fit for the upper management aspect of the procedures. I can better work with multiple groups and be able to reason out a fair schedule for groups to follow. The middle management…   Read more»

]]> 95f753df4be62fe1adc5d02929ced0f2 https://medicaldevicecourses.com/activity/p/14194/ Wed, 15 May 2019 18:52:56 -0400 One aspect of low severity risk that people need to understand is that no matter what it is going to occur. You try your hardest to avoid these situations with sampling an strong quality establishment but it is never going…   Read more»

]]> ba347122c3474bb9ec8d1cea359e98c4 https://medicaldevicecourses.com/activity/p/14193/ Wed, 15 May 2019 18:52:55 -0400 I was not aware that you have to pay to view the regulations. I am sure that it does help in the upkeep of the companies that are writing the regulations but I do think this favors innovations from current…   Read more»

]]> 327415b2a04c25be7eaffa69fca9daaf https://medicaldevicecourses.com/activity/p/14191/ Wed, 15 May 2019 18:52:54 -0400 Risk management meetings in my opinion are the most successful with a great deal of varying backgrounds. When creating a risk document it is important to encompass all of the possible negative outcomes. For my company they are categorized by…   Read more»

]]> 0976bd3d16a69da82dd11a64b7c14d2f https://medicaldevicecourses.com/activity/p/14052/ Wed, 15 May 2019 18:51:28 -0400 Validation in a way is an abbreviated version of the verification. It will allow the user to guarantee that the device or fixture is still functioning at its necessary caliber. It can begin with something as simple as checking the…   Read more»

]]> 04a0f7a4161d8b757869ae78fbe11b7d https://medicaldevicecourses.com/activity/p/14049/ Wed, 15 May 2019 18:51:26 -0400 As you near the verification process the design review meetings become very important as they are a great opportunity for coworkers, management, or even document control to realize an issue in your verification before it is initiated. Once initiated and…   Read more»

]]> 4b6b505b833e47b3eaa10385e081d817 https://medicaldevicecourses.com/activity/p/14042/ Wed, 15 May 2019 18:51:21 -0400 For a verification that I was recently working on we tried very hard to make sure the verification was written in a way that deviation could be avoided. We attempted to run the test ourselves as well as making sure…   Read more»

]]> a0b58ba12d46739584b86fe15a617bfc https://medicaldevicecourses.com/activity/p/13879/ Wed, 15 May 2019 17:09:03 -0400 I have been in many more meetings outside of the industry than I have meetings within the industry. In my fraternity we take very detailed minutes. Even though may seem this as unnecessary for a social organization but it is…   Read more»

]]> d70bd21e2ab0999a976cf357e3ecc27a https://medicaldevicecourses.com/activity/p/13878/ Wed, 15 May 2019 17:09:02 -0400 Through my experience I have seen very few cases when a validation is not required. I believe a lot of the requirements come from internal pressure and may not be directly required by the FDA or ISO audits. When in…   Read more»

]]> 85d6dd85fa09ddb8cd58fe2a24a26ab2 https://medicaldevicecourses.com/activity/p/13877/ Wed, 15 May 2019 17:09:02 -0400 I was lucky enough to have the opportunity to work on a Test Method validation that went into a design review. One thing I have noticed is that people will often make it seem like they have something to say…   Read more»

]]> 1f0955b2e06997a2da95d2aafe52eeed https://medicaldevicecourses.com/activity/p/13777/ Wed, 15 May 2019 17:08:07 -0400 For a study to be considered to have followed the scientific method it must have an experimental and a control group. It is sad to know people are being told they are being treated but they are actually reviving no…   Read more»

]]> d98ee67b4360d9d288ae963984174efd https://medicaldevicecourses.com/activity/p/13775/ Wed, 15 May 2019 17:08:06 -0400 I believe that if a clinical study is to occur the study should occur as a double blind study. Any bias that could alter the outcome of the study should be avoided at all cost. It is normal to want…   Read more»

]]> 6acbbf6ec6e97dee885b4f1e693af1d0 https://medicaldevicecourses.com/activity/p/13772/ Wed, 15 May 2019 17:08:04 -0400 I understand that it is normal to worry about the life of another human being but it is a moment where the livelihood of the masses matters more than the individual. One thing that is not often mentioned is that…   Read more»

]]> 8212d10cee6902b6e52a92bc7109695e https://medicaldevicecourses.com/activity/p/13634/ Wed, 15 May 2019 17:06:46 -0400 Advertising and marketing are very dynamic fields to be involved in. The regulations from television networks and now the huge increase of digital video recording products has put a huge halt to the use of basic commercials. Also, the increase…   Read more»

]]> e780b6aa41ea1107e8cbd550372a492d https://medicaldevicecourses.com/activity/p/13493/ Wed, 15 May 2019 17:05:22 -0400 Joining a partnership is very intimidating based on it is truly impossible to fully know someone until possibly when it is too late. When looking for a partner above all I think the most important thing to me would have…   Read more»

]]> edae9bca7ebdbe8ca494f9211429968e https://medicaldevicecourses.com/activity/p/13491/ Wed, 15 May 2019 17:05:21 -0400 I think this is an unbelievably interesting question to discuss. I do not I have ever looked into a company’s corporate structure, possibly due to a lack of knowledge on the subject, but I have definitely looked into the stock…   Read more»

]]> 731f3b12d30ebf9e8f9b6a51bafbee1f https://medicaldevicecourses.com/activity/p/13302/ Wed, 15 May 2019 17:03:44 -0400 I have assisted in an audit for the quality department and was honestly amazed in the company’s systematic ability to answer questions correctly and intelligently. The biggest lesson that I have learned from seeing an audit is to never give…   Read more»

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