https://medicaldevicecourses.com/members/jl959/activity/ Activity feed for jl959. Fri, 24 Apr 2026 17:00:45 -0400 https://buddypress.org/?v= en-US 30 hourly 2 4030cae2c2d4a31d20a4323a73dddcd3 https://medicaldevicecourses.com/activity/p/19233/ Mon, 02 Dec 2019 02:06:39 -0500 I personally felt that this course was very helpful to me, since it provided me with more insight into all the steps required to develop, manufacture, and release a medical device. It was interesting learning about the different departments and…   Read more»

]]> 9ad7ea54b943b9085a94764dcd15d630 https://medicaldevicecourses.com/activity/p/19232/ Mon, 02 Dec 2019 01:48:00 -0500 Written agreements are preferable since parties can keep a record of them, they can be submitted as physical evidence in court during disputes, and create a situation where it will be more difficult for one party to unjustly break the…   Read more»

]]> 04d319a804d7c8ae5ea7de03dd69c55f https://medicaldevicecourses.com/activity/p/19229/ Mon, 02 Dec 2019 01:26:21 -0500 There are several factors that need to taken into account when forming a Non-Disclosure Agreement. This agreement is meant to protect company information such as, trade secrets, client information, the manufacturing process, and sales and marketing plans. In general, NDA…   Read more»

]]> 2ea2280ace17719bd24ef2ee66be771d https://medicaldevicecourses.com/activity/p/19143/ Thu, 21 Nov 2019 22:47:24 -0500 If given the opportunity to choose my team members, I would go for members who are knowledgeable and experts in certain departmental roles. It is important that each departmental role is appropriately fulfilled by a capable team member, since it…   Read more»

]]> 036ba616928256350adbaa49e20bc469 https://medicaldevicecourses.com/activity/p/19141/ Thu, 21 Nov 2019 16:45:44 -0500 I would prefer to work in a strong matrix organization, where balance of power between the project managers and functional heads are less skewed. I believe this type of organization is best, since it forms a collaborative environment that discourages…   Read more»

]]> 9cf88ae94e12dc5c488e27c0e3eeb96c https://medicaldevicecourses.com/activity/p/19140/ Thu, 21 Nov 2019 16:20:50 -0500 I agree with some of these posts in that I would like to start with middle management and possibly transition into upper management later on. Upper management is strategic in looking at the big picture and future of the company,…   Read more»

]]> 9250e02868802c1eecafa777bffad21f https://medicaldevicecourses.com/activity/p/19116/ Mon, 18 Nov 2019 02:06:10 -0500 When selecting the method of risk management, I would take into account both the level of severity and occurrence. For high severity and high occurrence risks, I would definitely choose avoidance since that kind of risk is impossible to justify….   Read more»

]]> bbcf1427090184ce3fd1f8e48a9e993d https://medicaldevicecourses.com/activity/p/19114/ Mon, 18 Nov 2019 01:46:39 -0500 Since it is impossible for the company to predict what every person using their product will do, the team should always reduce or completely eliminate the possibility and level of harm before they place their product on the market. The…   Read more»

]]> 4cc54a63fb65abd3c2d4a1d41db89f38 https://medicaldevicecourses.com/activity/p/19108/ Mon, 18 Nov 2019 01:25:02 -0500 During risk management meetings, the project manager is in charge of facilitating the meeting and making sure that everyone’s inputs are considered. The team will identify the risk, calculate the probability of a hazardous situation turning into harm, and assess…   Read more»

]]> a08614f2d8f56979f1bc93cb284d2583 https://medicaldevicecourses.com/activity/p/19052/ Mon, 11 Nov 2019 01:37:58 -0500 While including all of these parts of the DDP is best practice, I would choose scope management plan and communications management plans as the most crucial. A well designed scope management plan will contain the stakeholders, scope statement, requirements, WBS,…   Read more»

]]> 96c263ca60b25c6f69d20b53b515f8d4 https://medicaldevicecourses.com/activity/p/19051/ Mon, 11 Nov 2019 01:14:48 -0500 The DID contains the desired inputs of the product. These inputs are more general, but provides all departments a rough idea of what needs to be achieved. The marketing department plays a major role in the DID since it researches…   Read more»

]]> 96ff7124dcea779f7cbc0d63e32ce261 https://medicaldevicecourses.com/activity/p/19021/ Fri, 08 Nov 2019 22:08:45 -0500 Design verification is a required part of design controls regardless of the type of medical device, but the necessity for validation varies. Verification and validation both take outputs into account, but verification compares it with the inputs and validation compares…   Read more»

]]> 80ab8c293628d1e1f470079eec0f8d1f https://medicaldevicecourses.com/activity/p/18990/ Sun, 03 Nov 2019 20:50:49 -0500 If used appropriately, design controls can lead a company to design and produce a product that is a success in terms of effectiveness, marketability, safety, and revenue generation. However, misuse or lack of certain design controls steps can prevent a…   Read more»

]]> 6dc6f68676b300d56f8362c46e64e136 https://medicaldevicecourses.com/activity/p/18989/ Sun, 03 Nov 2019 20:23:36 -0500 Verification is an important part of design controls since it ensures that the inputs match the outputs. It is a way to test the quality and consistency the products, making sure that all the design features of each tested sample…   Read more»

]]> af54b7b777446636f8be07db042f3329 https://medicaldevicecourses.com/activity/p/18987/ Sun, 03 Nov 2019 19:47:49 -0500 Design controls consist of nine parts, all of which contribute to developing a final product that is innovative, effective, and safe to use. During the planning phase, the project proposal gives management a broad idea of the project scope, demand…   Read more»

]]> f5b6dc2a04de8675310bf0f26677c876 https://medicaldevicecourses.com/activity/p/18932/ Mon, 28 Oct 2019 00:53:49 -0400 I agree with most of these posts in that placebos are both ethical and necessary in testing certain treatments. As long as the patient’s safety is not jeopardized, and the signed informed consent form properly details any risks(which must be…   Read more»

]]> 800d7a05a5a9d25c05598ce8dee00226 https://medicaldevicecourses.com/activity/p/18928/ Sun, 27 Oct 2019 23:55:45 -0400 A double blind study provides more assurance that the results of the study are as accurate and unbias as possible. For example, this type of study can be conducted by randomly assigning treatment of oral placebo sugar pills and pills…   Read more»

]]> 06acaca9a5af71d2789e38975e95a943 https://medicaldevicecourses.com/activity/p/18927/ Sun, 27 Oct 2019 23:21:37 -0400 A clinical background is definitely desired for anyone involved with clinical trials, especially for roles with direct patient interaction. For example, an investigator would really benefit from a clinical background since they will be responsible for ensuring the subject’s/patient’s safety…   Read more»

]]> a041f7ecd044ff8ea18556ac57154d6a https://medicaldevicecourses.com/activity/p/18852/ Sun, 20 Oct 2019 05:06:31 -0400 In my opinion, marketing is resonating with and capturing the attention of the audience by understanding their desires and showcasing why the proposed product will provide fulfillment. The marketing dept. must be experts on the concept of supply and demand,…   Read more»

]]> 77af0c5045d8d952593f98d6045f54b5 https://medicaldevicecourses.com/activity/p/18851/ Sun, 20 Oct 2019 04:44:23 -0400 Emotion intelligence is the ability to acquire and comprehend the emotions of one’s self and others. This skill is required for forging and handling all kinds of interpersonal relationships. In terms of selling, the sales representative will be able to…   Read more»

]]> a750fcd94932de57edcd77bb48963794 https://medicaldevicecourses.com/activity/p/18850/ Sun, 20 Oct 2019 04:04:34 -0400 According to Kidwell’s article, emotional intelligence is vital to a sales person’s success in generating revenue and retaining customers. Having the ability to acquire and comprehend the desires and emotions of anyone, will help the sales representative effectively pitch the…   Read more»

]]> e7900ac2a8c82c67a9a45c9e73f177e8 https://medicaldevicecourses.com/activity/p/18798/ Sun, 13 Oct 2019 08:16:12 -0400 I am in agreement with most of these posts in that I will also choose a Limited Liability Company as a start up. With a LLC, there are less restrictions on ownership, so members could be individuals, corporations, other LLCs,…   Read more»

]]> b5af169e185a0b8ffb2a925888be9521 https://medicaldevicecourses.com/activity/p/18797/ Sun, 13 Oct 2019 07:48:16 -0400 While a public company can sell stocks to anyone on the stock exchange, private company stocks are owned by a few individuals and cannot be traded publicly. A public company reaps the benefits of the public stock exchange, but it…   Read more»

]]> e202256292fd9a6102067d967d6e1807 https://medicaldevicecourses.com/activity/p/18780/ Fri, 11 Oct 2019 19:15:18 -0400 I would consider forming a partnership in the future, especially when launching a startup for the first time. Having a trustworthy partner can speed up the process of forming the company with additional financial backing with our joint investment and…   Read more»

]]> 3deb126fc7fc06051bdd0525328e669b https://medicaldevicecourses.com/activity/p/18741/ Mon, 07 Oct 2019 00:07:36 -0400 Having a clean and organized workspace is definitely important for a QC team member, but strong communication skills are also required. The QC department must be in constant contact with other departments like QA, in order to ensure they are…   Read more»

]]> 7fc511cf5bf1507757976b2c8dc724ee https://medicaldevicecourses.com/activity/p/18740/ Sun, 06 Oct 2019 23:53:16 -0400 In order to prevent unnecessary tension from forming between the quality dept. and other departments, there should be a clear form and frequency of communication established at the beginning of the project. To avoid any confusion later on, the regulatory…   Read more»

]]> 9a7c2105ee166ff2d1cb71ac5066ec50 https://medicaldevicecourses.com/activity/p/18722/ Sat, 05 Oct 2019 19:10:25 -0400 First and foremost, the company should invest in properly training all quality control department members. They also need to be informed of what is expected of them by the quality assurance department and FDA. Effective and sufficient communication between the…   Read more»

]]> 80ff8749727938dc82b423980c2c42f1 https://medicaldevicecourses.com/activity/p/18665/ Sun, 29 Sep 2019 22:52:46 -0400 While the FDA cannot predict every outcome from approving a certain medical device, it should definitely be held accountable in cases where the recall was issued due to gross negligence in their screening process. In September 2018, Alcon’s CyPass Micro-Stent…   Read more»

]]> 35e5726ee22a2ae38fa5dcf30ad8de79 https://medicaldevicecourses.com/activity/p/18664/ Sun, 29 Sep 2019 22:05:20 -0400 The FDA may appear too strict to industries trying to launch their medical device to the public market, but its guidelines exist to protect the wellbeing of the consumers and clients. In some ways, the FDA also protects the company…   Read more»

]]> 05c1b11f9015ed484afecdcd9b98488a https://medicaldevicecourses.com/activity/p/18645/ Fri, 27 Sep 2019 21:22:38 -0400 In recalls issued long after the product launch (ex: 5-8 years), the recall is usually not of serious health risk to the user (unless the product malfunction was due poor durability). Most recalls are initiated by the company itself, and…   Read more»

]]> 993becb968700dba5cdf530ac7e9f137 https://medicaldevicecourses.com/activity/p/18612/ Sun, 22 Sep 2019 20:25:08 -0400 The alternative to testing a substance’s biocompatibility through animal testing in vivo, is to perform toxicity tests in vitro. This, however, is often not enough to accurately estimate how the body’s immune response will be to the foreign substance. While…   Read more»

]]> 5ce5ce1a6c75e96ed19facebf46002ee https://medicaldevicecourses.com/activity/p/18611/ Sun, 22 Sep 2019 18:47:17 -0400 In order to prevent or minimize any pitfalls, I would first make sure to place and confirm the order as soon as possible once all the details are ironed out. Some details will be the agreed rate, amount and species…   Read more»

]]> 5f5c6bec63e26145f511a8395ffd9071 https://medicaldevicecourses.com/activity/p/18609/ Sun, 22 Sep 2019 18:13:35 -0400 In order to test the initial biocompatibility of the new biomaterial, I would use the ISO 10993-1 Test Matrix. Different tests like cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, and hemocompatibility tests will be performed based on the body contact level…   Read more»

]]> fa5292b49b3e5203c08f1c6de62ffcd3 https://medicaldevicecourses.com/activity/p/18531/ Sun, 15 Sep 2019 05:40:24 -0400 Due to how dependent the executing, monitoring & controlling, and closing phases of a project are on the planning phase, I believe the planning phase is the most important. The planning phase finalizes the members of the project team and…   Read more»

]]> 85077bdf08a851acb8e5904c546d3d66 https://medicaldevicecourses.com/activity/p/18530/ Sun, 15 Sep 2019 05:00:55 -0400 In terms of improving the overall current project, missing a milestone is considered a failure unless the milestone was unrealistic to begin with. It can be considered a success for improving future projects, after the project team creates detailed reports…   Read more»

]]> a9239517dbfbea8b8d919a1870d0ed4c https://medicaldevicecourses.com/activity/p/18529/ Sun, 15 Sep 2019 04:24:40 -0400 The Work Breakdown Structure is an important tool for the project management cycle, but only if it is created and used properly. Factors like dependencies, estimated costs, tasks, responsible individuals or departments for those tasks,  and other measurable quantities like…   Read more»

]]> 782f5488c04b6944f55859f210e514af https://medicaldevicecourses.com/activity/p/18477/ Sun, 08 Sep 2019 15:31:22 -0400 As most of you have mentioned, trying to get a job right after you get your Bachelor’s is preferred. However, without an established networking circle or prior experience in industry, this may prove too difficult and an MS may be…   Read more»

]]> 4de76326783ffd3ce511ecd84c3a4ecb https://medicaldevicecourses.com/activity/p/18476/ Sun, 08 Sep 2019 14:53:34 -0400 It should depend on the profession the student is aiming for. For someone planning to go the PHD route, he/she should focus more on informational courses to build a stronger academic base to supplement their research. In that case, the…   Read more»

]]> 106825680e148db9b89bafc373c5d04c https://medicaldevicecourses.com/activity/p/18475/ Sun, 08 Sep 2019 14:26:54 -0400 Currently, I am doing research at NJIT. I realize from the professor I am working with, that Academia truly does involve a lot of grant writing, politics with other schools and organizations, and multiple research projects alongside the teaching. While…   Read more»

]]> 9dbc7d5fe76e02529b2ef243cc9fc595 https://medicaldevicecourses.com/activity/p/18338/ Wed, 15 May 2019 21:47:26 -0400 I am not surprised by this disconnect since I understand why management would focus on positive reinforcement that differs from the employees’ needs. Management often rewards individual work and employees that surpass the quota. It is also easy for the…   Read more»

]]> a89b46a77f3df8a116eb0968f92dc77b https://medicaldevicecourses.com/activity/p/18337/ Wed, 15 May 2019 21:47:25 -0400 I believe most projects have more than one priority to focus on. Priorities can change as you progress through each stage of design control and project management. These priorities can include planning the specification, performing successful clinical trials, and choosing…   Read more»

]]> 7108793916d12b381e42a9366e3d020b https://medicaldevicecourses.com/activity/p/18336/ Wed, 15 May 2019 21:47:25 -0400 In order to build a maintain a good relationship with a vendor, you should first establish the best way to communicate with each other. You should specify all your needs and expectations, while ensuring that the vendor’s demands are met…   Read more»

]]> 92c2ccf24d0f14b54c15a72543f12b6f https://medicaldevicecourses.com/activity/p/18255/ Wed, 15 May 2019 21:46:43 -0400 For everyone in the survey, it can be a mix of different motivators that cause the employees to stay. I believe my main motivators will change overtime. For the timing being, I am focused on finding a job that will…   Read more»

]]> a207b5c4668ae7f061251d3aa53a7be2 https://medicaldevicecourses.com/activity/p/18253/ Wed, 15 May 2019 21:46:42 -0400 The PM definitely has an impact on the team’s motivation and productivity level. In order to successfully motivate the team, the PM must determine what motivates, demotivates, and keeps each member engaged. The PM should make an effort to understand…   Read more»

]]> cf321439466f14e00877e075317ed6de https://medicaldevicecourses.com/activity/p/18250/ Wed, 15 May 2019 21:46:41 -0400 Developing the schedule and determining the budget are done during the planning phase, before initiation of the clinical trails. To develop the schedule, the PM would need to take into account the amount of resources, the amount of team members…   Read more»

]]> f8bc776eb68bdffa55b8d7faa0e6be74 https://medicaldevicecourses.com/activity/p/18177/ Wed, 15 May 2019 21:46:02 -0400 While having a common communication management plan will save time, I believe it needs to be altered depending on the project. If the plan doesn’t help all participants clarify and voice their opinions effectively, delays would occur anyway. This could…   Read more»

]]> 81cf8bf1ae3866f027092c28d80025f4 https://medicaldevicecourses.com/activity/p/18176/ Wed, 15 May 2019 21:46:02 -0400 The WBS is a crucial part of the scope management process, no matter how small the project may be. It is responsible for breaking down all the tasks, delegating work to each team member, and making sure everyone is referring…   Read more»

]]> 010446aee56b915d83d9f4e0f8355d29 https://medicaldevicecourses.com/activity/p/18175/ Wed, 15 May 2019 21:46:01 -0400 Specifications should be broader during the beginning of design control, but should narrow down during the later stages. The project team can also refer to previous similar projects and compare previous specs to their estimated ones. Products sensitive to failure…   Read more»

]]> a3e905e599111a25f38aeb6f01502b84 https://medicaldevicecourses.com/activity/p/18126/ Wed, 15 May 2019 21:45:37 -0400 I believe it depends on how negative the SV is, and how close the team is to completing the project. If a negative SV was calculated closer to the beginning of the project, there is still enough time to speed…   Read more»

]]> cb56b73e4531b57d18cfefa1aed08cc1 https://medicaldevicecourses.com/activity/p/18125/ Wed, 15 May 2019 21:45:36 -0400 The project manager should discuss the amount of work and timeframe required for the project with potential members to make sure they can fully commit to the project. That timeframe should include vacation days, and additional days for unexpected emergencies….   Read more»

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