https://medicaldevicecourses.com/members/hc255/activity/ Activity feed for hc255. Fri, 24 Apr 2026 16:55:57 -0400 https://buddypress.org/?v= en-US 30 hourly 2 08d45368461e5ea6a323693ad080236c https://medicaldevicecourses.com/activity/p/15980/ Wed, 15 May 2019 19:15:51 -0400 I believe that I fall into that category because challenges throughout the work day keep things interesting. A repetitive job that does not push its workers is boring and will cause the workers to lose motivation and quit. What motivates…   Read more»

]]> c4926554d0e8f512de708459a87ad086 https://medicaldevicecourses.com/activity/p/15979/ Wed, 15 May 2019 19:15:50 -0400 Some ways to motivate the team members would be to encourage open communication amongst one another. This ensures that everyone is comfortable speaking to each other. Also, the project manager’s level of motivation does affect the team productivity because the…   Read more»

]]> 457115b6b238080376fade1fc8d07fae https://medicaldevicecourses.com/activity/p/15978/ Wed, 15 May 2019 19:15:50 -0400 As my colleagues have posted above, I also agree that I would prefer to continue as an engineer for a few years. In that process, I would like to quickly rise to Principal Engineer then transition into a managerial position…   Read more»

]]> d6f646853578530a84e19b82ba6ec4cd https://medicaldevicecourses.com/activity/p/15869/ Wed, 15 May 2019 19:14:46 -0400 I think it depends on the individual’s inner motives, goals, incentives, etc. Yes, Americans typically work more hours than most other countries sure. I personally work a bit more than 40hrs but that’s to minimize the workload for the next…   Read more»

]]> e12b80d0c5f317c78c80d58d568f6c4f https://medicaldevicecourses.com/activity/p/15868/ Wed, 15 May 2019 19:14:46 -0400 Retaining talent is very beneficial for several reasons. First, talent sometimes is hard to find. Talented individuals can potentially help those around them to complete projects and mentor others which is awesome in the workplace. Another benefit to this is…   Read more»

]]> 1bbc6d2a228b96fdeceb034d746a4fcd https://medicaldevicecourses.com/activity/p/15867/ Wed, 15 May 2019 19:14:45 -0400 What motivates me is my drive to help others. I believe in altruism and that we should strive to lend a hand to those in need. It’s those who deny help who need it the most. By helping others, you…   Read more»

]]> cd8ffde270272bbf35551cf462b08c45 https://medicaldevicecourses.com/activity/p/15711/ Wed, 15 May 2019 19:13:07 -0400 I agree with srg36 only if the selection of a new supplier would hinder the progress of a project or manufacturing of devices. But I also agree with ks629 that sticking with the same supplier does not solve the issue….   Read more»

]]> 60da6d18c1b5c959b1a50a5ab6553d49 https://medicaldevicecourses.com/activity/p/15710/ Wed, 15 May 2019 19:13:06 -0400 I had not gone thru the experience yet however I would imagine that if the team is not adequately prepared as Hiren stated, then that could be difficult to overcome. The timeline will get pushed back if there is a…   Read more»

]]> ec5a4b932200e21dedc7662826f913aa https://medicaldevicecourses.com/activity/p/15709/ Wed, 15 May 2019 19:13:05 -0400 The rate of return is similar to Return on investment (ROI) in the sense that there exists an amount or percentage of money coming back to the investor(s). Factors that influence the rate of return include the current climate in…   Read more»

]]> 91d26d8899cdafaf119bc10a3d6dba1d https://medicaldevicecourses.com/activity/p/15612/ Wed, 15 May 2019 19:08:14 -0400 I’ve experienced several different kinds of changes. One change I’ve implemented several times was the change of requirements listed in our CAD drawings. I also had to change document policies within SOPs to reflect current practices. These two changes would…   Read more»

]]> 1d958a5d1349cb62cd3f238ab590433f https://medicaldevicecourses.com/activity/p/15611/ Wed, 15 May 2019 19:08:14 -0400 I agree with the above posts that Metrics are essential to showing progress on any project, action, task, etc. Metrics not only show the status but can reveal critical information about how for example, Quality Systems or KPIs are performing…   Read more»

]]> 6ba6ed81cfeae7fabe7096d867cb1be2 https://medicaldevicecourses.com/activity/p/15610/ Wed, 15 May 2019 19:08:13 -0400 From my experience, the project schedule is a pretty solid way to track progress and determine potential end date of the project. However I agree with Aasutosh’s list and as934 addition to that list. These components all make up the…   Read more»

]]> 1d487d40f37c9c224a8a2534362138fb https://medicaldevicecourses.com/activity/p/15455/ Wed, 15 May 2019 19:06:34 -0400 From my experience and as msc52njit-edu and srg36 have mentioned, missing project members due to other commitments may affect the schedule variance. This is because without one person or two, etc. each action item that the team members are in…   Read more»

]]> 58a5e4c7d2c254b7ae1c97fbea620234 https://medicaldevicecourses.com/activity/p/15452/ Wed, 15 May 2019 19:06:32 -0400 I agree with everyone stated above that the project team should be open to communicating on a consistent basis. Communication is key because any issues that arise or may arise can be solved or addressed during meeting times instead of…   Read more»

]]> 61b57e08b780d426153ac2e517cbda56 https://medicaldevicecourses.com/activity/p/15450/ Wed, 15 May 2019 19:06:30 -0400 I agree with srg36 that the mentioned parts are very important in the project but are not the most important. I do however understand where rjs84 is coming from because if enough resources are not allocated to, for example, suppliers,…   Read more»

]]> bddbdcbf8487382dd34ea9018f7d6c47 https://medicaldevicecourses.com/activity/p/15399/ Wed, 15 May 2019 19:05:54 -0400 Design Validation is a pivotal stage in the product development cycle. I have experience regarding process validation but not design validation. However, user needs need to be met because that is directly coming from the customer who is providing the…   Read more»

]]> 9d33304c8b6ce33b682bf541a3ceaaa0 https://medicaldevicecourses.com/activity/p/15398/ Wed, 15 May 2019 19:05:54 -0400 Communication is key to any project team. Therefore, it is part of the project manager to facilitate an open environment for expressions of any concerns. One should first schedule a meeting with the PM to discuss the issue and then…   Read more»

]]> e51af270699a8d8efcc6ed7b1ad8acf1 https://medicaldevicecourses.com/activity/p/15397/ Wed, 15 May 2019 19:05:53 -0400 Typically the Project Manager would be notified ahead of time if it’s for a personal leave. If its an unexpected leave, then the PM would need to accommodate and move dates and action items around to the remaining members of…   Read more»

]]> 326b4c6a3a16bea15dfc775fcd0f9ae0 https://medicaldevicecourses.com/activity/p/15302/ Wed, 15 May 2019 19:05:01 -0400 The planning phase is very crucial and dictates the direction into which the team will take to accomplish the project goals. Overlapping tasks and projects is a common thing that sometimes inescapable. Communication between teams and project leads is essential…   Read more»

]]> 4f4c7aafde953607ffcf48197132db09 https://medicaldevicecourses.com/activity/p/15301/ Wed, 15 May 2019 19:05:01 -0400 In my company, one of the projects I am on closely resembles the second option. The second option is more relatable to a typical medical device product development cycle. One of the main problems is time. Assigned tasks or action…   Read more»

]]> 13b14312263c98f89041b1c8296dab40 https://medicaldevicecourses.com/activity/p/15300/ Wed, 15 May 2019 19:05:00 -0400 Currently, I work with the Process Validation aspect of our Cardio Surgery devices where I validate test methods. Deviations from protocol do occur every now and then but it is best to avoid them at all cost. One deviation I…   Read more»

]]> e5b2b27e75a3f9a3c1ab54c5d64951ab https://medicaldevicecourses.com/activity/p/15198/ Wed, 15 May 2019 19:03:54 -0400 Scheduling time for each person to complete assignments is definitely a bottleneck or can become one. One way to get around this is to schedule around the persons personal time off and have them approve of it. Another potential setback…   Read more»

]]> dbf4a85f8e1308635527592a0ff2430a https://medicaldevicecourses.com/activity/p/15197/ Wed, 15 May 2019 19:03:53 -0400 When I attended my first design review meeting, I did not participate much because my project lead and supervisor led most of the discussion. However, I had my validations and other documents prepared in case I was questioned on process…   Read more»

]]> 066fab03e2dc7b16e415c06f48445ea0 https://medicaldevicecourses.com/activity/p/15196/ Wed, 15 May 2019 19:03:53 -0400 On a daily basis, I almost always refer to the project plan (gaant chart) to give me guidance regarding the project deadlines and other assignments. This is particularly useful because I see what my action items are and what steps…   Read more»

]]> d8730c1d22e67bbf5693981d3a32d086 https://medicaldevicecourses.com/activity/p/15093/ Wed, 15 May 2019 19:02:59 -0400 Design review meetings at our company are very big in the sense that various members of several departments are invited. There, the project lead discusses the progress and changes in the device and asks for recommendations or is given feedback…   Read more»

]]> 16fb75098c02fffd4eb0b0835f448a71 https://medicaldevicecourses.com/activity/p/15091/ Wed, 15 May 2019 19:02:58 -0400 At Getinge, the engineers redline the latest version of the document depending on what changes need to be incorporated which can be given by various inputs of managers, personnel etc. From there, the engineer creates a change notice which contains…   Read more»

]]> 27cb6574a7e3922cfd09b78dfa205c6a https://medicaldevicecourses.com/activity/p/15090/ Wed, 15 May 2019 19:02:58 -0400 Engineering change orders allow engineers and others to make changes to documents, parts, etc. Typically one or more potential changes are discussed in a meeting or in a brief conversation. Then the person who becomes responsible for making the changes…   Read more»

]]> ecac53718ad2867cd93d0dfcd91bca81 https://medicaldevicecourses.com/activity/p/14970/ Wed, 15 May 2019 19:01:49 -0400 One of the tests I have seen done to check the integrity of the package is known as the burst test. Basically, it works just like it sounds. The package is connected to a machine that increases the internal pressure…   Read more»

]]> 8d5e876369e0c6d7401b64669c6e2900 https://medicaldevicecourses.com/activity/p/14969/ Wed, 15 May 2019 19:01:49 -0400 I believe that the company needs to decide using a risk-based approach. The medical device industry is governed by risk and because of that each decision made should account for potential setbacks that may arise. If the project is a…   Read more»

]]> 070ca31cd2808a91eb0c75542cce1a88 https://medicaldevicecourses.com/activity/p/14865/ Wed, 15 May 2019 19:00:53 -0400 I agree with puneet as that there aren’t many risks involved in performing v&v testing. The risks come into play if the requirements/specifications cannot be verified or need to be changed. If so, a design change review meeting may need…   Read more»

]]> b70f12888fdf6f3e3936c42626ef3e91 https://medicaldevicecourses.com/activity/p/14863/ Wed, 15 May 2019 19:00:53 -0400 Requirements for a project proposal are as follows: A description of the product along with its intended use and targeted customers. The market size and selling price should be included. There should be a section that discusses the products specifications…   Read more»

]]> 98bb5bcc4ad2595fabd1be6fea63463b https://medicaldevicecourses.com/activity/p/14854/ Wed, 15 May 2019 19:00:48 -0400 The quality plan or quality manual of a company shows the commitments of the company to quality and compliance. Upper management has executive responsibility. Some companies adopt clauses written within ISO13485:2016 to show compliance. The Quality Plan is designed to…   Read more»

]]> 489ddf1b14830e49fcd9a59ab429081e https://medicaldevicecourses.com/activity/p/14749/ Wed, 15 May 2019 18:59:44 -0400 In my current position, my team and I focus on Design Verification that is within Design Controls. Design Controls is an extremely important guide to engineers within the Medical Device industry. I believe that all of the steps of the…   Read more»

]]> 63fd58e87f776783668eff9fdbdf6277 https://medicaldevicecourses.com/activity/p/14746/ Wed, 15 May 2019 18:59:42 -0400 Since the FDA sees the Fitbit as a nonregulated device then it will stay as such. If the FDA considered the Fitbit as a medical device then regulations would need to be in place. Given that the device is a…   Read more»

]]> aee4b7446a2a818398ce2c36f9753f27 https://medicaldevicecourses.com/activity/p/14745/ Wed, 15 May 2019 18:59:42 -0400 Regulated industries are regulated with reason. Yes, it may hinder innovation however it is to ensure that the devices created are safe and effective for the general public. The regulations placed in the medical device industry are essential and necessary…   Read more»

]]> b5a695ff4d31ab68f119af4f02976614 https://medicaldevicecourses.com/activity/p/14580/ Wed, 15 May 2019 18:58:12 -0400 Verification and Validation should be done in accordance with Design Controls to ensure proper alignment with correct processes. Verification should be completed after outputs of a design have been established. Then as the device is being reviewed, validation should be…   Read more»

]]> 1eda660696668f289592b50527509174 https://medicaldevicecourses.com/activity/p/14578/ Wed, 15 May 2019 18:58:11 -0400 As as934 stated, it depends on the business. Upper management decides what the company should focus on given prior experience, etc. Low-priority projects are often put on the back burner because of that main reason – they are not important…   Read more»

]]> 3bcce54ce86e05f331619f97d5cfca06 https://medicaldevicecourses.com/activity/p/14576/ Wed, 15 May 2019 18:58:10 -0400 There are other engineering programs that better prepare the student for the given coursework, however, students should also take the initiative to work on their interpersonal skills. Given the nature of the business, students should still invest in school mainly…   Read more»

]]> 58ee8d4321a741986bcfa9c6007d54f8 https://medicaldevicecourses.com/activity/p/14393/ Wed, 15 May 2019 18:55:44 -0400 I believe that this isn’t restricted since bribery isn’t and shouldn’t be taken lightly. As stated in lecture, doctors would receive expensive packages and deals from company employees just so that their products can be favored over others regardless of…   Read more»

]]> 556a39d477dd345ef8c7587f48febe66 https://medicaldevicecourses.com/activity/p/14388/ Wed, 15 May 2019 18:55:41 -0400 Before discussing whether if an NDA acts as a substitute for a patent, it is worth mentioning the differences between the two. A patent is essentially a given right to the inventor saying that he/she or a group of people…   Read more»

]]> 45d8bbfba2653fbeeb1dd1e6ebbfa52d https://medicaldevicecourses.com/activity/p/14387/ Wed, 15 May 2019 18:55:40 -0400 For one of the company’s projects, myself and other colleagues had to sign an NDA regarding the project circumstances and to not disclose information or penalties will be enacted. Before signing, we had a small forum to discuss and deem…   Read more»

]]> 1769f9279cd276dc9652db29420097f0 https://medicaldevicecourses.com/activity/p/14248/ Wed, 15 May 2019 18:54:25 -0400 I would form a project team based on the recommendations from my manager. I would utilize my manager’s experience within the company to create a team that in theory can best perform to execute actions. As the project manager, I…   Read more»

]]> 78390a8ce6f5f2abbad5855288af0d48 https://medicaldevicecourses.com/activity/p/14247/ Wed, 15 May 2019 18:54:24 -0400 The organizational type that is most effective (best) depends on the team members associated with the project. Coming from a matrix organization, I believe that having a strong foundation from management will allow for flexibility of scheduling, however, this is…   Read more»

]]> 3f5485da71d0203a48c695188671efc5 https://medicaldevicecourses.com/activity/p/14246/ Wed, 15 May 2019 18:54:24 -0400 I work as a Quality Engineer in a company that runs as a matrix organization. The management provides excellent guidance to their team on various aspects. Also, the directors amongst the different departments are always willing to collaborate with each…   Read more»

]]> fa18373541b6ee233f246385e3b12598 https://medicaldevicecourses.com/activity/p/14134/ Wed, 15 May 2019 18:52:20 -0400 As a Quality Engineer, we have AQL levels in place in our drawings for the Quality Inspectors to use when inspecting incoming product that is to be used on the manufacturing floor. As neb2 stated, AQLs are Acceptance Quality Limits…   Read more»

]]> 5499539e043d6a058664b2a649d82776 https://medicaldevicecourses.com/activity/p/14132/ Wed, 15 May 2019 18:52:19 -0400 My company utilizes FMEA while the planning phase to assess risk. As mentioned in the lecture, FMEA is Failure Mode Effects Analysis. This systematic approach allows primarily those within the healthcare industry to evaluate a process to identify how failure…   Read more»

]]> 2192ce037f65486e82ce21021e54b02e https://medicaldevicecourses.com/activity/p/14131/ Wed, 15 May 2019 18:52:18 -0400 To deal with the high severity of risk would be to assess the potential outcomes that could arise. If at all possible, I would prefer to avoid the risk. This can be established through protocols that aim to move around…   Read more»

]]> 50a5df98b4e5f415ee5bc74e2b80635e https://medicaldevicecourses.com/activity/p/13978/ Wed, 15 May 2019 17:10:05 -0400 In the company I work for, I’ve seen several user requirements documents as well as risk analysis forms which include user requirements embedded with defined risk levels. User requirements documents help define the product because they come from the customer’s…   Read more»

]]> 32f329f57e272f6592f18065356a6249 https://medicaldevicecourses.com/activity/p/13977/ Wed, 15 May 2019 17:10:05 -0400 Working in industry I’ve had the chance to utilize gaant charts to structure a project which is focused around transitioning our documents to the latest ISO 13485:2016 standard before audits this month. By doing so, I had to make sure…   Read more»

]]> ad1b66191ee0d9d6099ee9f475a351c8 https://medicaldevicecourses.com/activity/p/13976/ Wed, 15 May 2019 17:10:04 -0400 Design review meetings are essential to ensure that the design adheres to both each stage of the Product Development Process as well as provide feedback per each stage. One of the design meetings I went discussed the whereabouts of the…   Read more»

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